Spinal - Implants - Pedicular screws

1

1

Table of contents :

Introduction Universal Pedicular Screw System 2

Product feature 3-4

Indications & Contraindications 5

Ordering information Implants 14-48

Mono-Axial Screws (Reduction) 14-15

Mono-Axial Screws (non-Reduction) 16-17

Poly-Axial Screws (Reduction) 18-19

Poly-Axial Screws (non-Reduction) 20-21

Set screw & Crosslinks 22

Dynamic Poly-Axial Screws (Reduction) 23-24

Dynamic Poly-Axial Screws (non-Reduction) 25-26

Rods 27-28

Hooks 29-32

Instruments 33-44

Containers & Trays 45-48

Surgical Technique Surgical Technique 6 - 13

Step 1 : Creating a screws hole 6

Step 2 : Radiographic control 7

Step 3 : Tapping 7

Step 4 : Screws insertion 8

Step 5 : Bending and attaching the rods 8

Step 6 : Rod placement 9

Step 7 : Insert the set screws 10

Step 8 : Insert the set screws(2) 11

Step 9 : Distraction / Compression 12

Step 10 : Tightening of the set screws 13

2

Introduction :

Key Features & Benefits :

Universal Pedicular Screw SystemScrew,hooks,rods and clamps

Highly versatile- Pre-bent rods- Optimal selection of implants- Easy-to-use instrumentation

Best performance- Cap thread designed to reduce cross threading- Visual and tactile indicators to ensure proper implant and instrument assembly- Buttress Thread enhances optimal bone purchase

Easy to use- Standard Instruments- Snap-on,telescoping transverse connectors provides easy attachment

Please refer to the package insert for a complete list of indications, contraindications, precautions and warnings.

The Spinal System is a set of instruments and implants for the surgical ap-proaches of deformity, degenerative and trauma indications.

Universal Pedicular Screw System

The Spinal System is a set of instruments and implants for the surgical ap

3

Product featuresPedicular Screw :

Locking Nut• Single size• Stable thread profile• Unique rotating saddle design or single piece

Screw Head• Unique thread design• Low profile• Color code by size• Reduction & Non-Reduction• Polyaxial and Monoaxial

Non-Reduction ScrewScrew heads are color coded by screw diameter

Reduction Screw

The Spinal Fixation System is an internal fixation device for spinal surgery comprising of pedicle screws, connectors, rods, housings and transverse link assemblies. Various forms and sizes of implants are available so that adaptations can be made to take into account the pathology and individual patient.

Screw Shaft• Self-tapping design• Diameters are from 4.5mm to 8.5mm• Increased pull-out strength

• Easy rod capture (50° rom)

4.5mm 5.5mm 6.5mm 7.5mm

Single Piece Set Screw (Optional)

Set Screw

The Spinal Fixation System is an internal fixation device for spinal surgery

4

Product featuresCross-Link :

Rotaion

Translation

Angulation

5

Indications / Contraindications :

Indications

Contraindications (Contraindications include, but are not limited to) :

1 Degenerative spondylolisthesis 2 Fracture 3 DDD (confirmed by patient history and radiographic studies) 4 Spinal tumors 5 Dislocation 6 Scoliosis 7 Kyphosis 8 Failed previous fusion 9 Having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint 10 Who are receiving fusions using autogenous bone graft only 11 Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below) 12 Who are having the device removed after the development of a solid fusion mass

1 Active infectious process or significant risk of infection (immunocompromise) 2 Signs of local inflammation 3 Fever or leukocytosis 4 Morbid obesity 5 Pregnancy 6 Mental illness 7 Grossly distorted anatomy caused by congenital abnormalities. 8 Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery. 9 Rapid joint disease, bone absorption, osteopenia, osteomalacia and/or osteoporosis. Osteoporosis or osteopenia is a relative contraindication since this condition may limit the degree of obtainable correction, stabilization, and/or the amount of mechanical fixation. 10 Suspected or documented metal allergy or intolerance. 11 Any case not needing a bone graft and fusion. 12 Any case where the implant components selected for use would be too large or too small to achieve a successful result. 13 Any case that requires the mixing of metals from two different components or systems. 14 Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality. 15 Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance. 16 Any patient unwilling to follow postoperative instructions.

When used as a fixation system of the non-cervical posterior spine in skeletally mature patients, the When used as a fixation system of the non-cervical posterior spine in skeletally mature patients,

Spine System is indicated for one or more of the following:

6

Confirm by using the Tester whether the

created screw hole has deviated out of the bone or not.

Determine the screw insertion point, and use the

starter Awl to drill a hole into the cortical bone in

the decided position. AWL SCC 110-0211

TESTER SCC110-0410

Surgical Technique :

Step 1 : Creating a screw hole

Instrument :

SCC110-0211 AWL

SCC110-0311 Probe(Straight)

SCC110-0410 Tester

Insert the pedicle probe into the hole , and gently

push it into the pedicle.

PROBE (STRAIGHT)

SCC110-0311

7

Step 2 : Radiograhic control

Instrument :

SCC110-0110 Guide Pin 100mm

SCC110-0120 Guide Pin 100mm w.Stop

When implementing radiographic control meas-

ures, use the pedicle marker.

Step 3 : Tapping

Instrument :

SCC110-0540/C Tap 4.5mm

SCC110-0550/C Tap 5.5mm

SCC110-0560/C Tap 6.5mm

SCC110-0570/C Tap 7.5mm

SCC110-0580/C Tap 8.5mm

SCC110-0410 Tester

Carry out tapping using the tap, the size of which

should match that of the screw. The screw is not a

self-tapping type. After reconfirming by using the

Tester.

GUIDE PIN 100 SCC110-0110

GUIDE PIN 100+STOP SCC110-0120

TAP SCC110-0XXX

TESTER SCC110-0410


8

Step 5 : Bending and attaching the rod

Instrument :

SCC110-1520 French Bender

It is not possible to obtain a sufficient tightening strength at the connection unless the rod securely touches the screw head bottom. For a safe connec-tion, bend the rod appropriately. ( see fig I , II , III )

This operation is particularly Important when usingthe monoaxial screw.

Step 4 : Screw insertion

Instrument :

SCC110-0951 Polyaxial Screw Driver Shaft

SCC110-0955 Monoaxial Screw driver Shaft

SCC110-2425 M Screw driver (Medium)

SCC110-0951C Polyaxial Screw Driver Shaft , Cannulated

SCC110-0955C Monoaxial Screw driver Shaft , Cannulated

Attach the screwdriver to the screw. The screw-

driver is equipped with a merchanism to safely

grasp the screw. After the screw is inserted, the

driver comes off from the screw when turning the

Nut counter clockwise.

Fig. I Fig. II Fig. III

FRENCH BENDERSCC110-1520


POLYAXIAL SCREWDRIVER SHAFT SCC110-0951/C

SCREWDRIVER (MEDIUM) SCC110-2425M

MONOAXIAL SCREWDRIVER SHAFT SCC110-0955/C

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Step 6 : Rod insertion

Instrument :

SCC110-1211 Rod Holder

Attatch the rod to the screw head by use of a Rod Holder.

ROD HOLDERSCC110-1211


10

Step 7 : Insert the Set Screw

When the rod is not securely touching the screw head base,(Fig.2) sufficient tightening strengh cannot be obtained at the connection. For a safe conection, it is necessary to push the rod into the screw bottom.

To attach the screw and the rod closely,the rod

pusher or the rod fork.

This operation to push the rod into the screw bottom is especially important when using the

monoaxial screw.

Self holding

Fig. I Fig. II

ROD PUSHERSCC110-1711

ROD FORKSCC110-1810


11

Step 8 : Insert the Set Screw(2)

Instrument :

SCC 110-1711 Rod Pusher

SCC 110-1810 Rod Fork

SCC 110-1920 Persuader

Before putting the plug into the screw, confirm that the rod is securely touching the screw head bottom as shown in the left figure marked with "O" . In the case marked with "X", make sure that the rod securely touches the screw head bottom in place, by bending or pushing the rod place, by using the rod approximator.

Fig. I Fig. II

ROD PUSHERSCC110-1711

PERSUADERSCC110-1920

ROD FORK (Adjustable)SCC110-1810


12


Step 9 : Compression / Distraction

Instrument :

SCC110-2711 Compressor

SCC110-1311 Rod Clamp

SCC110-2811 Distractor

Use the distraction forceps to distract the construct into the desired position. Then provisionally tighten the set screw. Once distraction is achieved in all levels final tighten all set screws.

Use the compression forceps to compress the construct into the desired position. then proci-sionally tighten the set screw. Once distraction is achieved in all levels final tighten all set screws.

Final tightening illustrated in step 10

CompressorSCC110-2711

Rod campSCC110-1311

DistractorSCC110-2811

13

Step 10 : Tightening of the Set Screw

Instrument :

SCC110-2441 T-handle(Torque-limiter)

SCC110-2420 S Screw driver (small)

SCC110-2425 M Screw driver (medium)

SCC110-2430 L Screw driver (Large)

SCC110-2911 Anti-torque wrench

For the final tightening of the Set Screw, use the torque driver, the driver shaft, and the anti rotator handle.Procedure for using a torque-limiting driver is shown here as example.

Attach the anti rotator to the screw head and insert the driver shaft to tighten the Set Screw. The driver clicks and runs idle when it reaches the prescribed torque of 12 NM.

T-hadle(Torque-limiter)SCC110-2441

Screw driver (medium)SCC110-2420 SSCC110-2425 MSCC110-2430 L

Anti-torque wrenchSCC-110-2911


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Implants :

Mono-Axial Screw 4.5mm Reduction

MSR 08-4520 20mm

MSR 08-4525 25mm

MSR 08-4530 30mm

MSR 08-4535 35mm

MSR 08-4540 40mm

MSR 08-4545 45mm

MSR 08-4550 50mm

MSR 08-4555 55mm

MSR 08-4560 60mm


MSR 09-5520 20mm

MSR 09-5525 25mm

MSR 09-5530 30mm

MSR 09-5535 35mm

MSR 09-5540 40mm

MSR 09-5545 45mm

MSR 09-5550 50mm

MSR 09-5555 55mm

MSR 09-5560 60mm

Ordering Information :Mono-Axial Reduction Screws :

15

Implants :


MSR 10-6520 20mm

MSR 10-6525 25mm

MSR 10-6530 30mm

MSR 10-6535 35mm

MSR 10-6540 40mm

MSR 10-6545 45mm

MSR 10-6550 50mm

MSR 10-6555 55mm

MSR 10-6560 60mm


MSR 11-7520 20mm

MSR 11-7525 25mm

MSR 11-7530 30mm

MSR 11-7535 35mm

MSR 11-7540 40mm

MSR 11-7545 45mm

MSR 11-7550 50mm

MSR 11-7555 55mm

MSR 11-7560 60mm

Ordering Information :Mono-Axial Reduction Screws :

16

Implants :

Mono-Axial Screw 4.5mm Non-Reduction

MSS 08-4520 20mm

MSS 08-4525 25mm

MSS 08-4530 30mm

MSS 08-4535 35mm

MSS 08-4540 40mm

MSS 08-4545 45mm

MSS 08-4550 50mm

MSS 08-4555 55mm

MSS 08-4560 60mm


MSS 09-5520 20mm

MSS 09-5525 25mm

MSS 09-5530 30mm

MSS 09-5535 35mm

MSS 09-5540 40mm

MSS 09-5545 45mm

MSS 09-5550 50mm

MSS 09-5555 55mm

MSS 09-5560 60mm

Ordering Information :Mono-Axial Non-Reduction Screws :

17

Implants :


MSS 10-6520 20mm

MSS 10-6525 25mm

MSS 10-6530 30mm

MSS 10-6535 35mm

MSS 10-6540 40mm

MSS 10-6545 45mm

MSS 10-6550 50mm

MSS 10-6555 55mm

MSS 10-6560 60mm


MSS 11-7520 20mm

MSS 11-7525 25mm

MSS 11-7530 30mm

MSS 11-7535 35mm

MSS 11-7540 40mm

MSS 11-7545 45mm

MSS 11-7550 50mm

MSS 11-7555 55mm

MSS 11-7560 60mm

Ordering Information :Mono-Axial Non-Reduction Screws :

18

Implants :

Poly-Axial Screw 4.5mm Reduction

PSR 08-4520 20mm

PSR 08-4525 25mm

PSR 08-4530 30mm

PSR 08-4535 35mm

PSR 08-4540 40mm

PSR 08-4545 45mm

PSR 08-4550 50mm

PSR 08-4555 55mm

PSR 08-4560 60mm


PSR 09-5520 20mm

PSR 09-5525 25mm

PSR 09-5530 30mm

PSR 09-5535 35mm

PSR 09-5540 40mm

PSR 09-5545 45mm

PSR 09-5550 50mm

PSR 09-5555 55mm

PSR 09-5560 60mm

Ordering Information :Poly-Axial Reduction Screws :

19

Ordering Information :Poly-Axial Reduction Screws :

Implants :


PSR 10-6520 20mm

PSR 10-6525 25mm

PSR 10-6530 30mm

PSR 10-6535 35mm

PSR 10-6540 40mm

PSR 10-6545 45mm

PSR 10-6550 50mm

PSR 10-6555 55mm

PSR 10-6560 60mm


PSR 11-7520 20mm

PSR 11-7525 25mm

PSR 11-7530 30mm

PSR 11-7535 35mm

PSR 11-7540 40mm

PSR 11-7545 45mm

PSR 11-7550 50mm

PSR 11-7555 55mm

PSR 11-7560 60mm

20

Implants :

Poly-Axial Screw 4.5mm Non-Reduction

PSS 08-4520 20mm

PSS 08-4525 25mm

PSS 08-4530 30mm

PSS 08-4535 35mm

PSS 08-4540 40mm

PSS 08-4545 45mm

PSS 08-4550 50mm

PSS 08-4555 55mm

PSS 08-4560 60mm


PSS 09-5520 20mm

PSS 09-5525 25mm

PSS 09-5530 30mm

PSS 09-5535 35mm

PSS 09-5540 40mm

PSS 09-5545 45mm

PSS 09-5550 50mm

PSS 09-4555 55mm

PSS 09-5560 60mm

Ordering Information :Poly-Axial Non-Reduction Screws :

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Ordering Information :Poly-Axial Non-Reduction Screws :


PSS 10-6520 20mm

PSS 10-6525 25mm

PSS 10-6530 30mm

PSS 10-6535 35mm

PSS 10-6540 40mm

PSS 10-6545 45mm

PSS 10-6550 50mm

PSS 10-6555 55mm

PSS 10-6560 60mm


PSS 11-7520 20mm

PSS 11-7525 25mm

PSS 11-7530 30mm

PSS 11-7535 35mm

PSS 11-7540 40mm

PSS 11-7545 45mm

PSS 11-7550 50mm

PSS 11-7555 55mm

PSS 11-7560 60mm

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Ordering Information :Set screw and Cross-Link :

Set screw

CHM01-10 With Saddle

CHM01-12 Without Saddle

Crosslink

SCC0120-0035

Range

40-45 mm

SCC0120-0042 45-55 mm

SCC0120-0050 55-65 mm

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Implants :

Dynamic Poly-Axial Screw 4.5mm Reduction

DPR08-4520 20mm

DPR08-4525 25mm

DPR08-4530 30mm

DPR08-4535 35mm

DPR08-4540 40mm

DPR08-4545 45mm

DPR08-4550 50mm

DPR08-4555 55mm

DPR08-4560 60mm


DPR09-5520 20mm

DPR09-5525 25mm

DPR09-5530 30mm

DPR09-5535 35mm

DPR09-5540 40mm

DPR09-5545 45mm

DPR09-5550 50mm

DPR09-5555 55mm

DPR09-5560 60mm

Ordering Information :Dynamic Poly-Axial Reduction Screws: Non-fusion

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Ordering Information :Dynamic Poly-Axial Reduction Screws: Non-fusion

Implants :


DPR10-6520 20mm

DPR10-6525 25mm

DPR10-6530 30mm

DPR10-6535 35mm

DPR10-6540 40mm

DPR10-6545 45mm

DPR10-6550 50mm

DPR10-6555 55mm

DPR10-6560 60mm


DPR11-7520 20mm

DPR11-7525 25mm

DPR11-7530 30mm

DPR11-7535 35mm

DPR11-7540 40mm

DPR11-7545 45mm

DPR11-7550 50mm

DPR11-7555 55mm

DPR11-7560 60mm

25

Implants :

Dynamic Poly-Axial Screw 4.5mm Non-Reduction

DPS08-4520 20mm

DPS08-4525 25mm

DPS08-4530 30mm

DPS08-4535 35mm

DPS08-4540 40mm

DPS08-4545 45mm

DPS08-4550 50mm

DPS08-4555 55mm

DPS08-4560 60mm


DPS09-5520 20mm

DPS09-5525 25mm

DPS09-5530 30mm

DPS09-5535 35mm

DPS09-5540 40mm

DPS09-5545 45mm

DPS09-5550 50mm

DPS09-5555 55mm

DPS09-5560 60mm

Ordering Information :Dynamic Poly-Axial Non-Reduction Screws : Non-fusion

26

Ordering Information :Dynamic Poly-Axial Non-Reduction Screws : Non-fusion

Implants :


DPS10-6520 20mm

DPS10-6525 25mm

DPS10-6530 30mm

DPS10-6535 35mm

DPS10-6540 40mm

DPS10-6545 45mm

DPS10-6550 50mm

DPS10-6555 55mm

DPS10-6560 60mm


DPS11-7520 20mm

DPS11-7525 25mm

DPS11-7530 30mm

DPS11-7535 35mm

DPS11-7540 40mm

DPS11-7545 45mm

DPS11-7550 50mm

DPS11-7555 55mm

DPS11-7560 60mm

27

Ordering Information :Rod to rod connectors :

Implants :

Extention connectorEC1-0001

Parallel connectorPC-1-0001

28

Ti Rod (Straight)

SCC02-0040 40mm

SCC02-0050 50mm

SCC02-0060 60mm

SCC02-0070 70mm

SCC02-0080 80mm

SCC02-0090 90mm

SCC02-0100 100mm

SCC02-0110 110mm

SCC02-0120 120mm

SCC02-0130 130mm

SCC02-0140 140mm

SCC02-0150 150mm

SCC02-0160 160mm

SCC02-0170 170mm

SCC02-0180 180mm

SCC02-0190 190mm

SCC02-0200 200mm

SCC02-0250 250mm

SCC02-0300 300mm

SCC02-0350 350mm

SCC02-0400 400mm

SCC02-0500 500mm

SCC02-0600 600mm

Ordering Information :Rods :

Ti rod curved

SCC03-0080 80mm

SCC03-0120 120mm

SCC03-0160 160mm

29

Narrow laminar hook

HS21-0504 20mm

HS21-0505 21mm

HS21-0506 22mm

HS21-0507 23mm

HS21-0508 24mm

HS21-0509 25mm

HS21-0510 26mm

Pedicle hook

HS20-0804 20mm

HS20-0805 21mm

HS20-0806 22mm

HS20-0807 23mm

HS20-0808 24mm

HS20-0809 25mm

HS20-0810 26mm

Ordering Information :Hooks :

30

Wide larminar hook

HS22-0704 20mm

HS22-0705 21mm

HS22-0706 22mm

HS22-0707 23mm

HS22-0708 24mm

HS22-0709 25mm

HS22-0710 26mm

Angled larminar hook

HS23-0505 20mm

HS23-0507 21mm

HS23-0509 22mm

HS23-0511 23mm

HS22-0505 24mm

HS22-0507 25mm

HS22-0509 27mm

HS22-0511 29mm


31

Laminar hook (Left)

HS25-0505 24mm

HS25-0507 26mm

HS25-0509 28mm

HS25-0511 30mm

Laminar hook (Right)

HS26-0505 24mm

HS26-0507 26mm

HS26-0509 28mm

HS26-0511 30mm

Laminar hook w. Extended body

HS27-0504 23.5mm

HS27-0505 24.5mm

HS27-0506 25.5mm

HS27-0507 26.5mm

HS27-0508 27.5mm

HS27-0509 28.5mm

HS27-0510 29.5mm


32

Implants :

SCC110-0110 GUIDE PIN 100mm

SCC110-0120 GUIDE PIN 100mm W.STOP

Ordering Information :Instruments :Pins :

33

SCC110-0211 AWL

SCC110-0321 PROBE (CURVED)

Ordering Information :Instruments :

34

SCC110-0410 TESTER


SCC110-0311 PROBE (STRAIGHT)

35

SCC110-0630 T-HANDLE LARGE

SCC112-0610 T-HANDLE SMALL

SCC110-2441 TORQUE LIMITING T-HANDLE12 nm


36

SCC110-0640 I-HANDLE

SCC110-0641 EXTENDED I-HANDLE


37

TAP : NON-CANNULATED

SCC110-0540 4.5mm

SCC110-0550 5.5mm

SCC110-0560 6.5mm

SCC110-0570 7.5mm

TAP : CANNULATED

SCC110-0540C 4.5mm

SCC110-0550C 5.5mm

SCC110-0560C 6.5mm

SCC110-0570C 7.5mm

Rod Template

RT-1-0001 200 mm


38

SCC110-0951

SCC110-0955

POLY-AXIAL SCREWDRIVER SHAFT

MONO-AXIAL SCREWDRIVER SHAFT

SCC110-0951C POLY-AXIAL SCREWDRIVER SHAFT , CANNULATED

SCC110-0955C MONO-AXIAL SCREWDRIVER SHAFT , CANNULATED

SCC110-2420 S SCREW DRIVER (SMALL)

SCC110-2425 M SCREW DRIVER (MEDIUM)

SCC110-2430 L SCREW DRIVER (LARGE)

SCC110-3311 TRANSVERSE WRENCH TIP


39

SCC110-1211 ROD HOLDER

SCC110-1410 CUTTING FORCEP


40

SCC110-1311 ROD CLAMP

SCC110-1520 FRENCH BENDER


41

SCC110-1531 IN-SITU BENDER (L)

SCC110-1541 IN-SITU BENDER (R)


42

SCC110-1711 ROD PUSHER

SCC110-1810 ROD FORK (Adjustable)


43

SCC110-2911 ANTI-TORQUE WRENCH

SCC110-1920 PERSUADER

SCC110-2430 SCREW HOLDER


44

SCC110-2811 DISTRACTOR

SCC110-2711 COMPRESSOR


45

SCC110-0105 Instrument tray 1

SCC110-0106 Instrument tray 2

SCC110-0100 Container for instruments

Ordering Information :Containers & Trays :

46

SCC110-0102 TRAY RODS 1(INCL. COVERING PLATE)

SCC110-0103 TRAY HOOKS 2(INCL. COVERING PLATE)

Ordering Information :Trays :

47

SCC110-0104 Screw caddy

SCC110-0101 Container for spinal implants

Ordering Information :Containers & Trays :

48

SCC110-0107 SPARE-LID(FOR SCC 110-0102 / 0103)

Ordering Information :Lid :

4949

Rev.1.00

Spinal - Implants - Pedicular screws

Health & Medicine

reduction screw screw

screw diameter reduction

spinal system

set screw crosslinks

spinal fixation system

monoaxial screws reduction

spine system

screws hole