(510(k) Summary) - Food and Drug Administration · Day 8 * Day 9 * Day 10 Day 15. Day 11. Day 30 * Day 39. Day 42 Day 45 Day 50 * Day 60. Day 50 * Day 55 Day 60. Day 70 Day 77 Day

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(510(k) Summary)

Product: HammerLock® 2

Submitter Information

BioMedical Enterprises, Inc. 14785 Omicron Drive, Ste. 205 San Antonio, Texas 78245 Telephone: (210) 677-0354 Fax: (210) 677-0355 Contact: Joe W. Soward Date Prepared: October 31, 2013

Classification name: Smooth or Threaded Metallic Bone Fastener (21 CFR 888.3040)

Classification: Class II Product Code: HTY Common/Usual Name: Intramedullary Bone Fastener Proprietary Name: HammerLock® 2

Intended Use:

The HammerLock® is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

Substantial Equivalence:

The HammerLock® 2 is substantially equivalent to the predicate BME HammerLock® cleared in K131640.

Device Description The HammerLock® 2 is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for fingers and toes. The HammerLock® 2 device is situated in the intramedullary space and the legs extend into the cancellous bone. After reaching body temperature, the legs fully deflect outward to create an anchoring force. The changes for the HammerLock® 2 system involve design changes to the implant and new disposable instrumentation.

Records processed under FOIA Request #2015-1875; Released by CDRH on 11-28-2016.

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or call 301-796-8118.

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K133520 Page 1 of 2

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Technological Characteristics Comparison to the Predicates

Product Name: HammerLock® 2 New device

Predicate HammerLock® (K131640)

Raw Material: Nitinol, per ASTM F2063-05

Nitinol, per ASTM F2063-05

Sizes: 17, 20, 22, and 25 mm 12, 14, 16, 19, 22 mm Styles: Straight and 10 degree Angled Straight and 10 degree angled

Pre-Operative Storage:

Room temperature Must be frozen prior to use

Heat Source: Fully transformed at body temperature

Fully transformed at body temperature

Implant Dimensions: The new HammerLock® 2 device is longer than the predicate K131640 HammerLock®. The length is added to the proximal side of the implant (the portion designed to be inserted into the proximal phalanx). The extended proximal length of the HammerLock® 2 allows for better fixation. Performance Bench Testing: Standard ASTM F382-99 was used to compare the mechanical bending parameters of the new HammerLock® 2 to the predicate K131640 HammerLock®. The results showed that all of the new HammerLock® 2 designs exceed the stiffness and strength of the predicate. Standard ASTM F2129-08 was used to compare the corrosion resistance of representative samples of the new HammerLock® 2 to technical literature and to predicate SmartToe devices (K070598). Test results demonstrate that the HammerLock® corrosion resistance is adequate according to technical literature and substantially equivalent to that of the SmartToe.



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Indications for Use 510(k) Number (if known): Device Name: HammerLock® 2 Indications For Use: The HammerLock® 2 is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes. Prescription Use __X_ AND/OR Over-The-Counter Use _______ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) __________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of __1___



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K133520

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file:///C|/Users/SMW/Desktop/2015-1875/DocMan%20Files/K133520%20-%20HammerLock%202%20Discussion%20(part%201).html[10/4/2016 5:04:58 PM]

Hi Dave, Thank you for clarifying several items on the HammerLock 2 for me. Just wanted to send you a brief meeting recap with thetracking link attached for the official record. No need to respond if this summary look satisfactory to you. Thanks again.

-Bryan Bryan B. Pinder Reviewer Joint and Fixation One Branch Division of Orthopedic Devices FDA - CDRH - ODE Tel: 301-796-6412

(b)(4) Confidential and Proprietary Information



4/30/13 version

510(k) COVERSHEET for DCC

510(k) Number: K133520 Review Records: X DocMan

� Paper (only applies to original 510(k)s assigned prior to 1/28/2013) 510(k) in eCopy-only Pilot: X Yes � No

Interim Decision (RTA1, TH, AI): � RTA1 (refuse to accept)

1. Put file on hold shelf

� TH (telephone, email or fax hold) 1. Put file on hold as of ________________ (date of last concurrence in CTS). 2. Issue auto-generated acknowledgement letter from APPS to applicant. 3. If paper review records, add copy of the letter to jacketed submission and

put file on hold shelf. 4. If DocMan review records, put file on hold shelf. 5. If eCopy-only pilot, no further steps.

� AI (AI mailed letter) 1. Put file on hold as of date on attached hold letter. 2. Mail the attached digitally signed and dated hold letter. 3. If paper review records, add copy of the letter to jacketed submission and


Final Decision (review finished): Follow appropriate processing steps

� SE (all SE codes)

� NSE (all NSE codes)

� Other (DR, EX, FB, NA, ND, NF, OD, PE, etc.) _________ (code)



510(k) No.DeviceSponsor/ApplicantLead ReviewerDate In for Lead Reviewer

Day 8 *Day 9 *Day 10Day 15

Day 11Day 30 *Day 39

Day 42

Day 45Day 50 *Day 60

Day 50 *Day 55Day 60Day 70Day 77Day 79 *Day 83Day 86 *Day 90Day 92 *Day 101

¹ Office Suggested Target

Unadjusted FDA due date

TH or AI and File To BC

For SI Recommendation of Telephone Hold (TH) Email or Additional Information (AI) Letter:

Friday, November 22, 2013

Assign consults

Friday, December 27, 2013

MDUFA III RTA Auto-Email (Date NOT adjusted) Saturday, November 30, 2013

If "potential NSE" anticipated, discuss with BC/DDD

Adjusted Milestone Date

Substantive Review (Note: This begins only after file is ACCEPTED, which should be no later than day 16)

MilestoneMonday, December 30, 2013

Consulting Reviews to lead reviewer

Milestone

Hammerlock 2

DCC Receipt Date: First day

BC Concurrence on RTADDD Concurrence on RTA Monday, November 25, 2013

Friday, November 22, 2013Lead Reviewer Recommendation into CTS

Friday, November 15, 2013

Refuse-to-Accept Review (decision required by Day 15)

BC Concurrence on PI recommendation in CTS

Preliminary recommendation for "Substantive Interaction" (SI) to BC ¹

Friday, January 03, 2014

For SI Recommendation of "Proceed Interactively" (PI): (Note: for PI, you are REQUIRED to interact with the sponsor prior to forwarding a final recommendation to your BC. Proceeding interactively means that you will NOT put the file on hold.)

File Placed on Hold

Brief Management on Close-out Plan

Friday, January 31, 2014

Friday, February 07, 2014Issue SE/NSE Letter to 510(k) StaffFDA Due Date (Adjusted for holidays and weekends)

Friday, January 03, 2014Lead Reviewer: PI Recommendation in CTSMilestone

Milestone dates that would have fallen on a holiday or weekend will adjust automatically, and will be noted with a "*"

Tuesday, January 14, 2014Friday, January 24, 2014

Thursday, February 13, 2014Friday, February 14, 2014

Consulting reviews to lead reviewer Friday, January 31, 2014

Monday, February 24, 2014Missed MDUFA Decision (MMD)

Send final information requests to sponsor¹Receive responses to final requests from sponsor¹

Thursday, February 06, 2014SE/NSE Letter and File to BC

For New TRADITIONAL 510(k) Submissions and Response to RTA1 Div./Branch:

MDUFA III SI Due Date Tuesday, January 14, 2014


Tuesday, November 26, 2013

Biomedical Enterprises, Inc

Friday, December 13, 2013

Thursday, February 13, 2014

Tuesday, December 24, 2013

DDD Concurrence on PI Recommendation in CTS

Milestone

DIVISION 510(k) MILESTONE WORKSHEET



Enter the receipt and due dates (from CTS) in these boxes (MM/DD/YYYY or M/D/YY)

DOD/JFDB1

Thursday, January 09, 2014

K133520



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Predicate: K131640-DSR

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration CDRH/ODE/DOD/JFDB1

WO66 RM1500 10903 New Hampshire Ave

Silver Spring, MD 20993-0002 301-796-6412

Premarket Notification [510(k)] Review

Date: January 6, 2014 To: FILE From: Bryan Pinder Subject: Traditional 510(k)# K133520 Applicant: Biomedical Enterprises, Inc Device Trade Name: Hammerlock 2

Correspondent: Joe Soward Correspondent Title:

Consultant Firm (if Applicable): Phone: (210) 677-0354 Email: [email protected]

FDA Received Date: November 15, 2013 Due Date: January 14, 2014

Reg #: 888.3040 Reg Name: Intramedullary Bone Fastener

Class: II Product Code(s): HTY

Predicate Devices: 510(k) # Pro Code Device Name Company K131640 HTY Smooth or threaded metallic bone

fastener Biomedical Ent., Inc.

Review Summary The subject device is a Intramedullary Bone Fastener with the following Indications for Use: “The HammerLock® 2 is indicated for small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.” It is for Rx use. The subject device is similar in design and function to the sponsor’s own predicate. The design and dimensional similarities and differences are described in Section III below. One items was resolved interactively. Recommendation I recommend that the Hammerlock 2 is/are Substantially Equivalent (SE)

Review Team Lead Reviewer Bryan Pinder (CDRH/ODE/DOD/JFDB1)



K133520 Lead Memo Biomedical Enterpris... Hammerlock 2 Page 2 of 11





































Digital Signature Concurrence Table Reviewer Sign-Off




Food and Drug Administration 10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002

BioMedical Enterprises, Incorporated Mr. Joe W. Soward Director, Quality, Compliance and Regulatory Affairs 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245 Re: K133520 Trade/Device Name: HammerLock® 2 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: November 7, 2013 Received: November 15, 2013 Dear Mr. Soward: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set



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January 9, 2014

Page 2 – Mr. Joe W. Soward forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure



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(b)(5)




Food and Drug Administration 10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002

BioMedical Enterprises, Incorporated Mr. Joe W. Soward Director, Quality, Compliance and Regulatory Affairs 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245 Re: K133520 Trade/Device Name: HammerLock® 2 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: November 7, 2013 Received: November 15, 2013 Dear Mr. Soward: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set



RPJ

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January 9, 2014

Page 2 – Mr. Joe W. Soward forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure



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(b)(5)

























4/30/13 version

510(k) COVERSHEET for DCC

510(k) Number: K133520 Review Records: X DocMan

Paper (only applies to original 510(k)s assigned prior to 1/28/2013)

510(k) in eCopy-only Pilot: X Yes No

Interim Decision (RTA1, TH, AI): RTA1 (refuse to accept)

1. Put file on hold shelf

TH (telephone, email or fax hold) 1. Put file on hold as of ________________ (date of last concurrence in CTS). 2. Issue auto-generated acknowledgement letter from APPS to applicant. 3. If paper review records, add copy of the letter to jacketed submission and


AI (AI mailed letter) 1. Put file on hold as of date on attached hold letter. 2. Mail the attached digitally signed and dated hold letter. 3. If paper review records, add copy of the letter to jacketed submission and


Final Decision (review finished): Follow appropriate processing steps

SE (all SE codes)

NSE (all NSE codes)

Other (DR, EX, FB, NA, ND, NF, OD, PE, etc.) _________ (code)



K133520 Page 1 of 2

(510(k) Summary) JN- 9 2014Product: HammerLock® 2


BioMedical Enterprises, Inc.14785 Omicron Drive, Ste. 205San Antonio, Texas 78245Telephone: (210) 677-0354Fax: (210) 677-0355Contact: Joe W. Soward

Date Prepared: October 31, 2013


Classification: Class 11Product Code: HTYCommon/Usual Name: Intramedul lary Bone FastenerProprietary Name: HammerLock®) 2

Intended Use:

The HammerLocklo is indicated for:Small bone reconstruction and fusion such as inter-digital fusion offingers and toes.


The HammerLock® 2 is substantially equivalent to the predicate BME HammerLock®cleared in K 131640.

Device Description

The HammerLock® 2 is a nitinol implant that comes in a range of sizes to provideintramedullary fixation for fingers and toes. The HammerLock® 2 device is situated inthe intramedullary space and the legs extend into the cancellous bone. After reachingbody temperature, the legs fully deflect outward to create an anchoring force.

The changes for the HamnmerLock® i2 system involve design changes to the implantand new disposable instrumentation.

5-1



K133520 Page 2 of 2


Product Name: HammerLocke 2 PredicateNew device HammerLock® (K 131640)

Raw Material: Nitinol, per ASTM Nitinol, per ASTMF2063-05 F2063-05

Sizes: 17, 20, 22, and 25 mm 12, 14, 16, 19, 22 mm

Styles: Straight and 10 degree Angled Straight and 10 degree angled

Pre-Operative Room temperature Must be frozen prior to useStorage:

Heat Source: Fully transformed Fully transformed at bodyat body temperature temperature

Implant Dimensions:

The new HammerLock®9 2 device is longer than the predicate K13 1640 HammerLock®. Thelength is added to the proximal side of the implant (the portion designed to be inserted into theproximal phalanx). The extended proximal length of the HammerLock®) 2 allows for betterfixation.

Performance Bench Testinga:Standard ASTM F382-99 was used to compare the mechanical bending parameters of the newHammerLock®R 2 to the predicate K13 1640 HammerLock®. The results showed that all ofthe new HammerLock® 2 designs exceed the stiffness and strength of the predicate.

Standard ASTM F2 129-08 was Used to compare the corrosion resistance of' representativesamples of the new HammerLock® 2 to technical literature and to predicate SmartToedevices (K070598). Test results demonstrate that the HammerLock® corrosion resistance isadequate according to technical literature and substantially equivalent to that of the SmartToe.

5-2




Food and Drug Administation10903 New Harpshire AvenueDocment Control Center - W066-G609Silver Spring, MD 20993-0002

January 9, 2014

BioMedical Enterprises, IncorporatedMr. Joe W. SowardDirector, Quality, Compliance and Regulatory Affairs14785 Omicron Drive, Suite 205San Antonio, Texas 78245

Re: K133520Trade/Device Name: HammerLock®& 2Regulation Number: 21 CER 888.3040Regulation Name: Smooth or threaded metallic bone fixation fastenerRegulatory Class: Class IIProduct Code: HTYDated: November 7, 20 13Received: November 15, 2013

Dear Mr. Soward:

We have reviewed your Section 51 0(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to-devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liabilitywarranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class IlI (PMA),it may be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CFR 803); good manufacturing practice requirements as set



Page 2 - Mr. Joe W. Soward

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronicproduct radiation control provisions (Sections 53 1-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for Your device on our labeling regulation (2 1 CFR Part 801), pleasecontact the Division of Small Manufacturers, International and..Con1sumer Assistance at its toll-free nurnb& (800) 638-2041 or (301) 796-7 100 or at its Internet addresshttD://vwwwfda.ov/MedicalDevices/ResourcesforYot/lndustrvdefaul.htm. Also. please notethe regulation entitled. "Misbranding by reference to premarketnotification" (21 CFR Part807.97). For questions regarding the reporting of adverse events tinder the MDR regulation (21CFER Part 803 ), please go to.http://wNN-A.fda.g6v/MedicalDevices/Safetv/ReportaProblem/default.htm for the CORI-Is Officeof Surveillance and Biometrics/Division of Postrnarket Surveillance.

You may obtain other general information on Your responsibilities under the Act from theDivision of Small Mainufacturers, International and Consumer Assistance at its toil-free number(800) 638 2041 or (301) 796-7100 or at its Internet addresslittD://w),%w.fda.szov/MedicalDevices/ResourcesforYou/industrv/default.hiin.

Sincerely yours.

RonadRJean -S for

Mark N. MelkersonDirectorDivision of Orthopedic DevicesOffice of Device EvaluationCenter for Devices and

Radiological Health

Enclosure



Indications for Use

510(k) Number (if known): K1 33520

Device Name: HammerLock® 2

Indications For Use:

The HammerLock® 2 is indicated for:

Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

Prescription Use _X AND/OR Over-The-Counter Use ___

(Part 21 CER 801 Su~bpart 0) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON.ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1. of 1

Di'S' of',0 bith8V'4e.d~cQVijcs

4-1




ss Food andi Drug Administation

Silver Spring, ME) 20993-0002

January 9, 2014

BioMedical Enterprises, IncorporatedMr. Joe W. SowardDirector, Quality, Compliance and Regulatory Affairs14785 Omicron Drive, Suite 205San Antonio, Texas 78245

Re: Kl33520Trade/Device Name: H-ammerLockO 2Regulation Number: 21 CFR 888.3040Regulation Name: Smooth or threaded metallic bone fixation fastener*Regulatory Class: Class IIProduct Code: HTYDated: November 7, 20 13Received: November 15, 2013

Dear Mr. Soward:

We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liabilitywarranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class III (PMA),it may be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Reilister.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CFR 803); good manufacturing practice requirements as set




forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 53l1-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 80 1), pleasecontact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7 100 or at its Internet addresshttp://www.fda.e-ov/MedicalDevices/ResourcesforYoui/I ndustrv/default.hitm. Aliso, please notethe regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CFR Part 803), please go to.http):Iwwwv.fda.Rov/MedicalDevices/Safetv/RenortaProblem/default.htm for the CDRH's Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers. lntetniational and Consumer Assistance at its toll-free number(800) 638 2041 or (3)01) 796-7100 or at its Internet addresshttp://wvwv.fda-gov/MedicalDevices/ResourcesforYou/I ndustry/default.htm.

Sincerely yours.

Rona Id&N-Aea n -S for

Mark N. MelkersonDirectorDivision of Orthoped icDevicesOffice of Device EvaluationCenter for Devices and

Radiological Health

Enclosure




Concurrence & Template History Page

Full Submission Number: K133520

For Office of Compliance Contact Information:

httD)://insideportlets.fda.gov:901I0/portal/~age?) Dapeid=197.415881 & dadortial& schema=PORTAL&or2=3 18

For Office of Surveillance and Biometrics Contact Information:

http:7//insideportlets.fda.gov:90 I 0/p ortaI/nage? Dageid=197.415881 & dadportal& schema=PORTAL&orp=423

Digital Signature Concurrence TableReviewer Sign-Off Bryan Pinder

Branch Chief Sign-Off Casey Hanley 1/9/20 14

Division Sign-Off Ronald P. Jean -S2014.01.09 14:42:34 -05'O0'

f/t:BBPjnj:l1/6/14Template Name: K I(A) - SE after 1996

Template History:

Date of Update Byv Description of Update7/27/09 Brandi Stuart Added Updates to Boiler Table8/7/09 Brandi Stuart Updated HFZ Table1/11/10 Diane Garcia Liability/Warranty sentence added at bottom of I' page10/4/11 M. McCabe Janicki Removed IFU sheet and placed in Forms9/25/12 Edwena Jones Added digital signature format12/12/12 M. McCabe Janicki Added an extra line between letter signature block and the word

"Enclosure". Also, added a missing digit in 4-digit extension onletterhead zip code: "002' should be "0002".

4/2/2013 M. McCabe Janicki Edited sentence that starts "If you desire specific advice for yourdevice on our labeling regulation (21 CFR Part 801)."Replaced

_______________broken Compliance link with general link to DSMICA.4/12/20 13 Margaret McCabe Fixed a typo: Paragraph 1. final sentence. "We remind you, however:

Janicki that device labeling must be truthful."Replaced incorrectsemicolon with a comma.



Indications for Use

5 10(k) Number (if known): K 133520

Device Name: HammerLock@ 2

Indications For Use:

Trhe HammerLock® 2 is indicated for:

Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

Prescription Use _X_ AND/OR Over-The-Counter Use ____

(Part 21 CFR 801 Subpart D) (21 CFR 601 Subpart C)

(PLEASE DO NOT WRITE' BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Page 1 of 1I

Divs ~afg~p ievices

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Section

MDUFMA Cover sheet

1

CDRH Premarket Review Submission Cover Sheet 2

510(k) Cover Letter 3

Indications for Use Statement 4

510(k) Summary 5

Truthful and Accuracy Statement 6

Class III Summary and Certification 7

Financial Certification or Disclosure Statement 8

Declarations of Conformity and Summary Reports (Form 3654) 9

Executive Summary 10

Device Description 11

Substantial Equivalence Discussion 12

Proposed Labeling

A123-003, Rev. 1 Draft; Hammerlock 2 box label; Hammerlock 2 Technique Sheet; A125-001, Rev.1

13

Sterilization / Shelf Life 14

Biocompatibility 15

Software 16

Electromagnetic Compatibility / Electrical Safety 17

Performance Testing – Bench 18

Performance Testing – Animal 19

Performance Testing – Clinical (Certification of Compliance) 20





Form Approved: OMB No. 0910-0511 Expiration Date: April 30, 2016. See Instructions for OMB Statement.

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION MEDICAL DEVICE USER FEE COVER SHEET

PAYMENT IDENTIFICATION NUMBER: Write the Payment Identification number on your check.

A completed cover sheet must accompany each original application or supplement subject to fees. If payment is sent by U.S. mail orcourier, please include a copy of this completed form with payment. Payment and mailing instructions can be found at:http://www.fda.gov/oc/mdufma/coversheet.html

1. COMPANY NAME AND ADDRESS (include name,street address, city state, country, and post office code)

BIOMEDICAL ENTERPRISES INC14785 OMICRON DRSAN ANTONIO TX 78245US

1.1 EMPLOYER IDENTIFICATION NUMBER (EIN)

*****9344

2. CONTACT NAME

Joe Soward

2.1 E-MAIL ADDRESS

[email protected]

2.2 TELEPHONE NUMBER (include Area code)

210-677-0354

2.3 FACSIMILE (FAX) NUMBER (Include Area code)

210-677-0355

3. TYPE OF PREMARKET APPLICATION (Select one of the following in each column; if you are unsure, please refer to theapplication descriptions at the following web site:http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm345263.htmSelect an application type: 3.1 Select a center [X] Premarket notification(510(k)); except for third party [X] CDRH [ ] 513(g) Request for Information [ ] CBER [ ] Biologics License Application (BLA) 3.2 Select one of the types below [ ] Premarket Approval Application (PMA) [X] Original Application [ ] Modular PMA Supplement Types: [ ] Product Development Protocol (PDP) [ ] Efficacy (BLA) [ ] Premarket Report (PMR) [ ] Panel Track (PMA, PMR, PDP) [ ] 30-Day Notice [ ] Real-Time (PMA, PMR, PDP)

[ ] 180-day (PMA, PMR, PDP)

4. ARE YOU A SMALL BUSINESS? (See the instructions for more information on determining this status) [ ] YES, I meet the small business criteria and have submitted the requiredqualifying documents to FDA

[X] NO, I am not a small business

4.1 If Yes, please enter your Small Business Decision Number:

5. FDA WILL NOT ACCEPT YOUR SUBMISSION IF YOUR COMPANY HAS NOT PAID AN ESTABLISHMENT REGISTRATIONFEE THAT IS DUE TO FDA. HAS YOUR COMPANY PAID ALL ESTABLISHMENT REGISTRATION FEES THAT ARE DUE TOFDA? [X] YES (All of our establishments have registered and paid the fee, or this is our first device, and we will register and pay the feewithin 30 days of FDA's approval/clearance of this device.) [ ] NO (If "NO," FDA will not accept your submission until you have paid all fees due to FDA. This submission will not be processed;seehttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053165.htm

for additional information)

6. IS THIS PREMARKET APPLICATION COVERED BY ANY OF THE FOLLOWING USER FEE EXCEPTIONS? IF SO, CHECKTHE APPLICABLE EXCEPTION. [ ] This application is the first PMA submitted by a qualified smallbusiness, including any affiliates

[ ] The sole purpose of the application is to supportconditions of use for a pediatric population

[ ] This biologics application is submitted under section 351 of thePublic Health Service Act for a product licensed for further manufacturinguse only

[ ] The application is submitted by a state or federalgovernment entity for a device that is not to be distributedcommercially

7. IS THIS A SUPPLEMENT TO A PREMARKET APPLICATION FOR WHICH FEES WERE WAIVED DUE TO SOLE USE IN APEDIATRIC POPULATION THAT NOW PROPOSES CONDITION OF USE FOR ANY ADULT POPULATION? (If so, the applicationis subject to the fee that applies for an original premarket approval application (PMA). [ ] YES [X] NO

PAPERWORK REDUCTION ACT STATEMENT Public reporting burden for this collection of information is estimated to average 18 minutes per response, including the time forreviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing

(b) (4)



"Close Window" Print Cover sheet

the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information,including suggestions for reducing this burden, to the address below.

Department of Health and Human Services, Food and Drug Administration, Office of Chief Information Officer, 1350 Piccard Drive,4th Floor Rockville, MD 20850 [Please do NOT return this form to the above address, except as it pertains to comments on the burden estimate.]

8. USER FEE PAYMENT AMOUNT SUBMITTED FOR THIS PREMARKET APPLICATION 31-Oct-2013

Form FDA 3601 (01/2007)

(b) (4)



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4‐1

Indications for Use 510(k) Number (if known): Device Name: HammerLock® 2 Indications For Use: The HammerLock® 2 is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes. Prescription Use __X_ AND/OR Over-The-Counter Use _______ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) __________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of __1___



5-1

(510(k) Summary)

Product: HammerLock® 2


BioMedical Enterprises, Inc. 14785 Omicron Drive, Ste. 205 San Antonio, Texas 78245 Telephone: (210) 677-0354 Fax: (210) 677-0355 Contact: Joe W. Soward Date Prepared: October 31, 2013


Classification: Class II Product Code: HTY Common/Usual Name: Intramedullary Bone Fastener Proprietary Name: HammerLock® 2

Intended Use:

The HammerLock® is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.


The HammerLock® 2 is substantially equivalent to the predicate BME HammerLock® cleared in K131640.

Device Description The HammerLock® 2 is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for fingers and toes. The HammerLock® 2 device is situated in the intramedullary space and the legs extend into the cancellous bone. After reaching body temperature, the legs fully deflect outward to create an anchoring force. The changes for the HammerLock® 2 system involve design changes to the implant and new disposable instrumentation.



5-2


Product Name: HammerLock® 2 New device

Predicate HammerLock® (K131640)

Raw Material: Nitinol, per ASTM F2063-05

Nitinol, per ASTM F2063-05

Sizes: 17, 20, 22, and 25 mm 12, 14, 16, 19, 22 mm Styles: Straight and 10 degree Angled Straight and 10 degree angled

Pre-Operative Storage:

Room temperature Must be frozen prior to use

Heat Source: Fully transformed at body temperature

Fully transformed at body temperature

Implant Dimensions: The new HammerLock® 2 device is longer than the predicate K131640 HammerLock®. The length is added to the proximal side of the implant (the portion designed to be inserted into the proximal phalanx). The extended proximal length of the HammerLock® 2 allows for better fixation. Performance Bench Testing: Standard ASTM F382-99 was used to compare the mechanical bending parameters of the new HammerLock® 2 to the predicate K131640 HammerLock®. The results showed that all of the new HammerLock® 2 designs exceed the stiffness and strength of the predicate. Standard ASTM F2129-08 was used to compare the corrosion resistance of representative samples of the new HammerLock® 2 to technical literature and to predicate SmartToe devices (K070598). Test results demonstrate that the HammerLock® corrosion resistance is adequate according to technical literature and substantially equivalent to that of the SmartToe.





Section 7 Class III Summary and Certification

These devices are Class II. This section is not applicable for this submission.

7-1



Section 8 Financial Certification

This submittal contains no information from clinical studies sponsored by BioMedical Enterprises, Inc. This section is not applicable for this submission.

8-1



Section 9 Standards Used for the HammerLock® 2

• ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants

• ASTM F899-12b Standard Specification for Wrought Stainless Steels for Surgical Instruments

• ASTM F366-10 Standard Specification for Fixation Pins and Wires • ASTM F382-99 Standard Test Specification and Test Method for Metallic Bone

Plates

• ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Methods to Determine the Corrosion Susceptibility of Small Implants.

• AAMI TIR 33-05 Sterilization of health care products-Radiation sterilization-Substantiation of 2 kGy as a sterilization dose-Method VD max

9-1





Please answer the following questions

Is this standard recognized by FDA 2 ? ..................................................................................................

FDA Recognition number 3 ....................................................................................................................

Was a third party laboratory responsible for testing conformity of the device to this standard identified in the 510(k)? ........................................................................................................................................

Is a summary report 4 describing the extent of conformance of the standard used included in the

If no, complete a summary report table.

Does the test data for this device demonstrate conformity to the requirements of this standard as it pertains to this device? ..........................................................................................................................

Does this standard include acceptance criteria? ...................................................................................

Does this standard include more than one option or selection of tests? ................................................

Were there any deviations or adaptations made in the use of the standard?.........................................

Were deviations or adaptations made beyond what is specified in the FDA SIS?.................................If yes, report these deviations or adaptations in the summary report table.

Were there any exclusions from the standard? .....................................................................................

Is there an FDA guidance 6 that is associated with this standard?.........................................................If yes, was the guidance document followed in preparation of this 510k? .............................................

Title of guidance:

1 The formatting convention for the title is: [SDO] [numeric identifier] [title of standard] [date of publication]

2 Authority [21 U.S.C. 360d], www.fda.gov/cdrh/stdsprog.html3 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/

search.cfm4 The summary report should include: any adaptations used to adapt to

the device under review (for example, alternative test methods); choices made when options or a selection of methods are described; deviations from the standard; requirements not applicable to the device; and the name and address of the test laboratory or

Department of Health and Human Services Food and Drug Administration

STANDARDS DATA REPORT FOR 510(k)s (To be filled in by applicant)

This report and the Summary Report Table are to be completed by the applicant when submitting a 510(k) that refer- ences a national or international standard. A separate report is required for each standard referenced in the 510(k).

TYPE OF 510(K) SUBMISSION

Traditional Special Abbreviated

STANDARD TITLE 1

Yes No

certification body involved in conformance assessment to this standard. The summary report includes information on all standards utilized during the development of the device.

5 The supplemental information sheet (SIS) is additional information which is necessary before FDA recognizes the standard. Found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

6 The online search for CDRH Guidance Documents can be found at www.fda.gov/cdrh/guidance.html

#

Form Approved: OMB No. 0910-0120; Expiration Date: 12/31/13

FORM FDA 3654 (12/10) Page 1 PSC Graphics (301) 443-6740 EF

510(k)? ..................................................................................................................................................

If yes, were deviations in accordance with the FDA supplemental information sheet (SIS) 5 ? .............

If no, include the results of testing in the 510(k).

If yes, report options selected in the summary report table.

If yes, report these exclusions in the summary report table.



EXTENT OF STANDARD CONFORMANCE SUMMARY REPORT TABLE

STANDARD TITLE

FORM FDA 3654 (12/10) Page 2

CONFORMANCE WITH STANDARD SECTIONS*SECTION NUMBER

TYPE OF DEVIATION OR OPTION SELECTED ❖

DESCRIPTION

JUSTIFICATION

CONFORMANCE?

Yes No

SECTION TITLE

SECTION NUMBER


DESCRIPTION

JUSTIFICATION

SECTION TITLE

SECTION NUMBER


DESCRIPTION

JUSTIFICATION

SECTION TITLE

* For completeness list all sections of the standard and indicate whether conformance is met. If a section is not applicable (N/A) an explanation is needed under “justification.” Some standards include options, so similar to deviations, the option chosen needs to be described and adequately justified as appropriate for the subject device. Explanation of all deviations or description of options selected when following a standard is required under “type of deviation or option selected,” “description” and “justification” on the report. More than one page may be necessary.

❖ Types of deviations can include an exclusion of a section in the standard, a deviation brought out by the FDA supplemental information sheet (SIS), a deviation to adapt the standard to the device, or any adaptation of a section.

N/A

CONFORMANCE?

Yes No N/A

CONFORMANCE?

Yes No N/A

Paperwork Reduction Act StatementPublic reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer 1350 Piccard Drive, Room 400 Rockville, MD 20850

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
















Title of guidance:










STANDARD TITLE 1

Yes No




#



510(k)? ..................................................................................................................................................








STANDARD TITLE

FORM FDA 3654 (12/10) Page 2



DESCRIPTION

JUSTIFICATION

CONFORMANCE?

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DESCRIPTION

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Yes No N/A



















Title of guidance:










STANDARD TITLE 1

Yes No




#



510(k)? ..................................................................................................................................................








STANDARD TITLE

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DESCRIPTION

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DESCRIPTION

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Yes No N/A



















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STANDARD TITLE 1

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510(k)? ..................................................................................................................................................








STANDARD TITLE

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DESCRIPTION

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DESCRIPTION

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#



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DESCRIPTION

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Section 10 Executive Summary

The HammerLock® 2 is a nitinol implant designed for intramedullary fixation of the fingers and toes. The implant is delivered to the operating room in sterile packaging and constrained in plastic instruments. The implant can be stored at room temperature prior to implantation. During surgery, the HammerLock® 2 implant is inserted into the small bones. One side of the implant conforms to the shape of the intramedullary space, while the other side is mechanically constrained in a closed position to allow insertion. After insertion, the implant is transformed by body temperature and expands to anchor itself in the bones. In this submittal, the new HammerLock® 2 device includes changes to the implant design, instrumentation, and surgical procedure.

10-1



Section 11 Device Description

General Description The HammerLock® 2 is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for fingers and toes. The HammerLock 2 device is situated in the intramedullary space and has legs extending into the cancellous bone. After the device is inserted into the intramedullary space, the legs deflect outward to create an anchoring force. The HammerLock 2 is an upgrade to the HammerLock device which is FDA cleared (K091951 and K131640) and marketed by BioMedical Enterprises, Inc. (BME). In this

Changes from Predicate The predicate for this submission is the upgraded HammerLock cleared in K131640. The HammerLock 2 features the following changes from K131640:

11-1





11-2




11-3




Engineering Drawings Engineering drawings for the HammerLock 2 are shown in the attachments.

Packaging and Sterilization The HammerLock 2 system comes packaged in two kits. All kits are provided sterile and for single-use. A validated cleaning, sealing and sterilization process is used for the HammerLock 2 system. 1. HammerLock 2 Implant Kit: The implant kit contains a HammerLock 2 implant pre-mounted on a plastic insertion stick. The kit is packaged in a thermoformed PETG plastic tray with Tyvek® 1073B lid. 2. HammerLock 2 Instrument Kits: There are two instrument kits, one for standard drilling and another for use with cannulated drill bits and temporary positioning wires. The standard kit contains a standard drill bit, two broaches, and a sizing guide, while the cannulated kit contains temporary positioning wires, cannulated drill bit, two broaches and a sizing guide. The kit is packaged in a thermoformed PETG plastic tray with Tyvek® 1073B lid. New box and label artwork is attached to conform to the FDA requirement of a legend for all symbols.

Surgical Procedure A new surgical procedure technique is attached. The procedure has been adjusted for easier insertion of the implant and show images of the new implant and instrument.

11-4





The new design of the HammerLock 2 allows for the implant to be inserted without pre-operative freezing. The proximal legs deflect downward upon insertion, whereas the distal legs are constrained mechanically in an insertion position. The constraint is removed after insertion is complete. The removal technique is also described. Manufacturing The HammerLock 2 implants are manufactured at BME’s facility in San Antonio, Texas. The nitinol raw material and validated processing steps and treatments are the same as for

11-5




(b)(4) Confidential and Proprietary Information - Drawings






















































Section 12 Substantial Equivalence

Table 12-1 compares the different properties of the HammerLock 2 and the predicate K131640, for this Traditional 510(k).

12-1




Discussion of How Comparison Supports Substantial Equivalence The HammerLock 2 is similar in material composition and has the same indications for use as the predicate. All of the technical characteristics are substantially equivalent to the

12-2




corresponding characteristics of the predicate device. There are differences in shape and size between the HammerLock® 2 and the predicate devices, however, these minor differences raise no new issues of safety and efficacy of the devices.

12-3









MADE IN USA

AXXXXXXX

BioMedical Enterprises, Inc.San Antonio, Texas 78245

Emergo EuropeMolenstraat 152513 BH The HagueThe Netherlands

Caution: U.S. Federal law restricts this deviceto sale by or on the order of a physician.EU REPRESENTATIVE

MFG BY

DO NOTREUSE

GAMMA STERILIZED CAUTION: SEEACCOMPANYING

DOCUMENTS

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Large ProximalMedium Distal

Large ProximalMedium Distal

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Technique

After performing necessary incisions and resections, open the HammerLock 2 Standard Drill Kit (DK-H2) and, using the 2.1mm Standard Drill Bit supplied, drill into the medullary canal of middle phalange until the attached plastic drill stop is reached or resistance from subchondral bone is met. Note: The HammerLock 2 Cannulated Drill Kit (DK-H2C) that includes a 0.035” K-wire is also available from BME.

2Remove drill stop and drill into the medullary canal of proximal phalange using drill bit until the positive stop (shoulder) is reached or resistance from subchondral bone is met.

1

3Using the HammerLock 2 Sizing Guide (H2SG) supplied in the Drill Kit, determine the depth of each drill hole in order to select the proper implant size.

4Using the Distal and Proximal Broaches supplied in the HammerLock 2 Drill Kit, broach into the distal and proximal canals, respectively, using an in-and-out motion without rotating. Make sure wide aspect of Broaches are parallel to the medial plane of the bone.

hammerlock2Records processed under FOIA Request #2015-1875; Released by CDRH on 11-28-2016.


While keeping the Retaining Tab in place, reduce the joint by pulling the middle phalange over exposed distal legs of the Implant.

Squeeze Retaining Tab to release Tab from Implant and fully reduce the joint.

87

Removal of Implant (If Necessary): Expose the joint 1-2mm and secure the HammerLock® with forceps. Distract the middle phalanx while using the forceps to pinch the distal arms of the implant together. To remove the proximal end, lock forceps onto the distal arms of the implant and gently rotate and distract the implant from the proximal phalange. If the implant is solidly connected, create a dorsal window to expose and remove the distal and/or proximal portion of the implant.

5Pull back on Slider Button on Inserter to release Implant from the Inserter.

Open the appropriate HammerLock 2 Implant Kit containing the HammerLock 2 implant preloaded onto the Implant Inserter. Insert the exposed proximal end of the Implant into the proximal phalange until the Retaining Tab makes contact with the bone.

6



Instructions for Use - Warnings and PrecautionsHammerLock® Intramedullary Nitinol Implant System

General

The HammerLock® 2 Intramedulary Nitinol Implant System gives the surgeon a means of intramedullary bone fixation and helps in the management of reconstructive surgery.

Basic Structure

The devices of the HammerLock® 2 Intramedullary Nitinol Implant Systems are made of biocompatible Nitinol and possess shape memory and superelastic properties. The HammerLock® 2 is a one-piece Nitinol device with legs that deflect outward in the medullary cavity and towards each other resulting in implant stabilization and compression.

Indications For Use

Small bone reconstruction and fusion such as in the phalanges of the fingers and toes.

Contraindications

• Pathologic conditions of bone such as osteopenia which would impair the ability to securely fix the implant.

• Foreign body sensitivity to metals including nickel. Where material sensitivity is suspected, appropriate tests should be made prior to implantation.

Warnings

• The HammerLock® 2 cannot be expected to replace normal healthy bone or withstand the stress placed upon the device by full or partial weight bearing or load bearing in the presence of nonunion, delayed union or incomplete healing. Therefore, it is important that immobilization of the treatment site using routine methods (casting, splints, etc...) be maintained until bone healing has occurred (4-6 weeks).

• Reduction of the site should be achieved and maintained after implanting the device. The compressive force of the HammerLock® 2 implant should not be relied upon to achieve closure or reduction of a fracture line.

• The HammerLock® 2 Intramedullary Nitinol Implant Systems have not been evaluated for safety and compatibility in the MR environment. The devices have not been tested for heating or migration in the MR environment.

• Any additional processing or reprocessing of this implant may affect the shape memory properties of the nitinol, changing or otherwise reducing the effectiveness of the implant.

• If sterilization is compromised prior to insertion, a different sterile implant will need to be used. Product cannot be re-sterilized due to the heat lability of the polycarbonate materials.

Clinical Use Considerations

HammerLock® 2 implants are provided for use where intramedullary fixation with multiaxial stabilization is desired.

Clinical Use Examples

Interphalangeal arthrodesis of the hand and foot.

Instructions

1. After performing necessary incisions and resections, open the HammerLock® 2 Standard Drill Kit (DK-H2) and, using the 2.1mm Standard Drill Bit supplied, drill into the medullary canal of middle phalange until the attached plastic drill stop is reached or resistance from subchondral bone is met.

2. Remove drill stop and drill into the medullary canal of proximal phalange using drill bit until the positive stop (shoulder) is reached or resistance from subchondral bone is met. Note: The HammerLock® 2 Cannulated Drill Kit (DK-H2C) that includes a 0.035” K-wire is also available from BME.

3. Using the HammerLock® 2 Sizing Guide (H2-SG) supplied in the Drill Kit,

Instructions for Use - Warnings and PrecautionsHammerLock® Intramedullary Nitinol Implant System

General

The HammerLock® 2 Intramedulary Nitinol Implant System gives the surgeon a means of intramedullary bone fixation and helps in the management of reconstructive surgery.

Basic Structure

The devices of the HammerLock® 2 Intramedullary Nitinol Implant Systems are made of biocompatible Nitinol and possess shape memory and superelastic properties. The HammerLock® 2 is a one-piece Nitinol device with legs that deflect outward in the medullary cavity and towards each other resulting in implant stabilization and compression.

Indications For Use

Small bone reconstruction and fusion such as in the phalanges of the fingers and toes.

Contraindications

• Pathologic conditions of bone such as osteopenia which would impair the ability to securely fix the implant.

• Foreign body sensitivity to metals including nickel. Where material sensitivity is suspected, appropriate tests should be made prior to implantation.

Warnings

• The HammerLock® 2 cannot be expected to replace normal healthy bone or withstand the stress placed upon the device by full or partial weight bearing or load bearing in the presence of nonunion, delayed union or incomplete healing. Therefore, it is important that immobilization of the treatment site using routine methods (casting, splints, etc...) be maintained until bone healing has occurred (4-6 weeks).

• Reduction of the site should be achieved and maintained after implanting the device. The compressive force of the HammerLock® 2 implant should not be relied upon to achieve closure or reduction of a fracture line.

• The HammerLock® 2 Intramedullary Nitinol Implant Systems have not been evaluated for safety and compatibility in the MR environment. The devices have not been tested for heating or migration in the MR environment.

• Any additional processing or reprocessing of this implant may affect the shape memory properties of the nitinol, changing or otherwise reducing the effectiveness of the implant.

• If sterilization is compromised prior to insertion, a different sterile implant will need to be used. Product cannot be re-sterilized due to the heat lability of the polycarbonate materials.

Clinical Use Considerations

HammerLock® 2 implants are provided for use where intramedullary fixation with multiaxial stabilization is desired.

Clinical Use Examples

Interphalangeal arthrodesis of the hand and foot.

Instructions

1. After performing necessary incisions and resections, open the HammerLock® 2 Standard Drill Kit (DK-H2) and, using the 2.1mm Standard Drill Bit supplied, drill into the medullary canal of middle phalange until the attached plastic drill stop is reached or resistance from subchondral bone is met.

2. Remove drill stop and drill into the medullary canal of proximal phalange using drill bit until the positive stop (shoulder) is reached or resistance from subchondral bone is met. Note: The HammerLock® 2 Cannulated Drill Kit (DK-H2C) that includes a 0.035” K-wire is also available from BME.

3. Using the HammerLock® 2 Sizing Guide (H2-SG) supplied in the Drill Kit,



Manufactured by:BioMedical Enterprises, Inc.14785 Omicron Drive, Suite 205San Antonio, Texas 78245Phone (210) 677-0354Fax (210) 677-0355Toll Free (800) 880-6528 A125-001 Rev 1

determine the depth of each drill hole in order to select the proper implant size.

4. Using the Distal and Proximal Broaches supplied in the HammerLock® 2 Drill Kit, broach into the distal and proximal canals, respectively, using an in-and-out motion without rotating. Make sure wide aspect of Broaches are parallel to the medial plane of the bone.

5. Open the appropriate HammerLock® 2 Implant Kit containing the HammerLock 2 implant preloaded onto the Implant Inserter. Insert the exposed proximal end of the Implant into the proximal phalange until the Retaining Tab makes contact with the bone.

6. Pull back on Slider Button on Inserter to release Implant from the Inserter.

7. While keeping the Retaining Tab in place, reduce the joint by pulling the middle phalange over exposed distal legs of the Implant.

8. Squeeze Retaining Tab to release Tab from Implant and fully reduce the joint.

Removal

Expose the joint 1-2mm and secure the HammerLock® 2 with forceps. Distract the middle phalanx while using the forceps to pinch the distal arms of the implant together. To remove the proximal end, lock forceps onto the distal arms of the implant and gently rotate and distract the implant from the proximal phalange. If the implant is solidly connected, create a dorsal window to expose and remove the distal and/or proximal portion of the implant.

European Representative:Emergo EuropeMolenstraat 15

2513 BH The HagueThe Netherlands

Tel: (31) (0) 70 345-8570Fax: (31) (0) 70 346-7299

Care and Caution

Inspect the sterile pouches used for the implants prior to use. Sterilization cannot be assured should not be used if pouch or seal is damaged.

Instruments

All instrumentation for the HammerLock® 2 System are provided sterile and are for single use only.

Storage

HammerLock® 2 implant and instrument kits should be stored at room temperature (50-80°F).

Shelf Life

HammerLock® 2 has a 5 year shelf life.

Customer Service

Additional information about the HammerLock® 2 implants and associated instrument kits is available from BME at any time (210-677-0354 or 800-880-6528) or contact your local HammerLock® 2 sales representative.

Manufactured by:BioMedical Enterprises, Inc.14785 Omicron Drive, Suite 205San Antonio, Texas 78245Phone (210) 677-0354Fax (210) 677-0355Toll Free (800) 880-6528 A125-001 Rev 1

European Representative:Emergo EuropeMolenstraat 15

2513 BH The HagueThe Netherlands

Tel: (31) (0) 70 345-8570Fax: (31) (0) 70 346-7299

determine the depth of each drill hole in order to select the proper implant size.

4. Using the Distal and Proximal Broaches supplied in the HammerLock® 2 Drill Kit, broach into the distal and proximal canals, respectively, using an in-and-out motion without rotating. Make sure wide aspect of Broaches are parallel to the medial plane of the bone.

5. Open the appropriate HammerLock® 2 Implant Kit containing the HammerLock 2 implant preloaded onto the Implant Inserter. Insert the exposed proximal end of the Implant into the proximal phalange until the Retaining Tab makes contact with the bone.

6. Pull back on Slider Button on Inserter to release Implant from the Inserter.

7. While keeping the Retaining Tab in place, reduce the joint by pulling the middle phalange over exposed distal legs of the Implant.

8. Squeeze Retaining Tab to release Tab from Implant and fully reduce the joint.

Removal

Expose the joint 1-2mm and secure the HammerLock® 2 with forceps. Distract the middle phalanx while using the forceps to pinch the distal arms of the implant together. To remove the proximal end, lock forceps onto the distal arms of the implant and gently rotate and distract the implant from the proximal phalange. If the implant is solidly connected, create a dorsal window to expose and remove the distal and/or proximal portion of the implant.

Care and Caution

Inspect the sterile pouches used for the implants prior to use. Sterilization cannot be assured and plate should not be used if pouch or seal is damaged.

Instruments

All instrumentation for the HammerLock® 2 System are provided sterile and are for single use only.

Storage

HammerLock® 2 implant and instrument kits should be stored at room temperature (50-80°F).

Shelf Life

HammerLock® 2 has a 5 year shelf life.

Customer Service

Additional information about the HammerLock® 2 implants and associated instrument kits is available from BME at any time (210-677-0354 or 800-880-6528) or contact your local HammerLock® 2 sales representative.



Section 14

Sterilization and Shelf Life

The following is the information recommended for inclusion with 510k submission per “Updated 501(k) Sterility Review Guidance K90-1; Guidance for Industry and FDA”. Sterilization Method Used Gamma irradiation is used to sterilize the HammerLock® 2. Description of the Method Used to Validate the Sterilization Cycle Sterilization of the HammerLock® 2 is identical to the HammerLock® predicate (K131640) and is achieved by gamma radiation to a sterility assurance level (SAL) of 10-6. The minimum permissible dose required to achieve the required SAL level is 25 kGy and was validated using standard AAMI TIR27:2001. The requirements of TIR27:2001 “Radiation sterilization – Substantiation of a 25 kGy as a sterilization dose – Method VD max” have been incorporated into AAMI TIR 33:2005 “Sterilization of health care products – Radiation sterilization – Substantiation of a selected sterilization dose – Method VD max.” at the 25 kGy dosage. Dose audits will be performed as prescribed by the standard. Description of the Packaging to Maintain the Device’s Sterility Sterilization will be maintained by packaging in thermoformed plastic trays with DuPont Tyvek™ 1073b lids sealed prior to sterilization. BME has validated sealing and sterilization processes for this method of packaging. A DuPont shelf life study demonstrated conclusively that these Tyvek™ lids when adhered to a thermoformed tray can maintain sterility for at least five years if package integrity is maintained.

14-1



Section 15

Biocompatibility

The patient contacting materials in the HammerLock® 2 system are listed below.

15-1




15-2




Section 16 Software

These devices do not include any software. This section is not applicable for this submission.

16-1



Section 17 Electromagnetic Compatibility and Electrical Safety

HammerLock 2 implants are made of medical grade titanium alloy, Nitinol (ASTM F 2063), a material that has an excellent history of electromagnetic compatibility. The HammerLock 2 has not been evaluated for safety and compatibility in the magnetic resonance (MR) environment. The HammerLock 2 has not been tested for heating or migration in the MR environment. There are no electronic components in any of the HammerLock 2 contained in this premarket notification submission. Thus, the electrical safety aspect of this section is not applicable to this premarket notification.

17-1



(b)(4) Confidential and Proprietary Information (b)(4) Confidential and Proprietary Information - Testing






































































































Section 19 Performance Testing - Animal

This submittal does not contain any animal testing to support equivalence. This section is not applicable for this submission.

19-1



Section 20 Performance Testing - Clinical

This submittal does not contain any clinical testing to support equivalence. This section is not applicable for this submission.

20-1



* Food and Drug AdministrationOffice of Device Evaluation &COVER SHEET MEMORANDUM Office ofIn Vitro Diagnostics and

Radiological Health

From: Reviewer Name Bryan Pinder

Subject: 510(k) Number K133520

To: The Record

Please list aTS decision code: SE - Substantially Equivalent

F] Refused to Accept (Note: this is considered the first review cycle. See screening checklist.)

FH Hold (Additional Information or Telephone Hold)

Z Final Decision (SE, SE with Limitations, NSE (select code below), Withdrawn, etc.)

Please complete the following for a final clearance decision (iLe, SE, SE with Limitations, etc.) YES NO

Indications for Use Page (Attach /FU)

510(k) Summary or 510(k) Statement (Attach Summary or Statement)

Truthful and Accurate Statement (Must be present for a FinalDecision) X

Is the device Class III? X

Does firm reference standards? (if yes, please attach Form 3654.) X

Is this a combination product? XIs this a reprocessed single use device? (See Guidance forlIndustryvand FDA Staff -MDUFMA -Validation Data in 510(k)sfor Reprocessed Single-Use Medical Devices.)

Is this device intended for pediatric use only?

Is this a prescription device? (If both prescription & OTC, check both boxes.) X

Is clinical data necessary to support the review of this 510(k)? XFor United States based clinical studies only, did the application include a completed Form FDA 3674, Certification withRequirements of ClinicalTrials.gov Data Bank? (if study was conducted in the United States and Form FDA 3674 was not Xincluded or was incomplete, then applicant must be contacted to obtain completed form.)

Does this device include an Animal Tissue Source? X

All Pediatric Patients age <= 21 X

Neonate/Newborn (Birth to 28 days) X

Infant (29 days to < 2 years) X

Child (2 years to < 12 years) xAdolescent (12 years to < 18 years) XTransitional Adolescent A (18 years to <21 years); Special considerations are being given to this group, different fromadults age >= 21 (different device design or tesating, different protocol procedures, etc.)

Transitional Adolescent B8(18 years to <21 years); No special considerations compared to adults >= 21 years)



Nanotechnology

Is this device subject to the Tracking Regulation? (Medical Device Tracking Guidance)x

Regulation Number: 21 CFR 888.3040

Class: 11

Product Code: HTY

Additional Product Codes:

Digital Signature Concurrence Table(Notall signatures may be required)

Branch Chief Sign-Off Case20l4.Olj[O9S49D4\,4cOSOO5 0

Ronald P. Jean,7SDivision Sign-Off

2014.01 .0904: 34:39 -05100'

