CDH - Sports Surgery Line...HTO plate specialists: Controlled resorbtion and Custom design — Standard design 20 years of proven efficacy Osteotwin References 1. Daculsi, G., O. Laboux,

eXperts in bone regeneration

Osteotwin™

Sports Surgery Line

Mineral

BonePhase

Bioactivity

MB

CPmicroporositymacroporosity

calciumphosphate

biphasic

About Biomatlante

Our MBCP™ Technology

Backed by 20 years of experience in the development and manufacturing of synthetic bone substitutes,

Biomatlante readily meets the challenge of constantly evolving its product line to meet today’s market

demands for new, more effective, generations of biomaterials and smart scaffolds for tissue regeneration

and minimally invasive surgical technologies.

More than 650 published studies, with 30 years of clinical experience

Biomatlante’s Bone Scaffolds have evolved to meet new biotechnological requirements stemming from tissue

engineering where surgeons need to combine scaffolds with biological fluids (bone marrow or mesenchymal stem

cells) or active agents.

Biomatlante leads the way in the development of smart scaffolds for use in numerous research programs seeking to

improve outcomes for particularly challenging patients.

The performance of MBCP™ is characterized by:

• Equivalent clinical outcome to autologous bone graft;• Fewer spinal wound healing problems than autologous grafts;• Avoidance of donor site pain and infections;• No allergenic reactions.

macroporosity

microporosity

100 µm2 µm

Mineral BonePhase

Bioactivity

MB

CPmicroporositymacroporosity

calciumphosphate

biphasic

MBCP™ Technology: worldwide reference in synthetic bone graft

Osteotwin™

Interference ScrewOsteotwin™ was designed to fulfill two core aims: provide appropriate mechanical properties necessary for ligament reconstruction whilst ensuring a regulated resorption and osteointegration to form architectural bone through hydrolysis.

Canulated Screw Design

The thread is specific to each screw diameter so as to systematically provide the maximum amount of contact between implant and bone.

Atraumatic thread for optimal contact

Non aggressive thread (to protect the ligament)

Graduated tapered design to optimize torque

Screw tip tailored to assist insertion into the bone tunnel

Auto stopper half head design

Lengths 25 and 30

The conical tip is shorter to increase threaded screw contact

Length 20

Headless to maximize the length of the screw

ACL Fixation System

Knee Cruciate Ligament Reconstruction Attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur

Polylactic Screws

Made of amorphous PLDLLA, Osteotwin™ Polylactic reduces inflammation risk.

Osteotwin™

Composite Screws

ACL Fixation System

KEY FEATURES KEY BENEFITS

CompositeScrew

Polymer & Ceramic Bioactive3

pH Neutral No reported cases of inflammation. No reported cases of kysts.*

Positive clinical response Architectural bone growth

MBCP™ Technology Greater corticalization*

PolylacticScrew

Biocompatible No rejection

Bio absorbable Non obstructive, in event of revision

Metal-like mechanical properties Necessary for indication requirements

75% PLDLLA & 25% BCP: the ideal ratio between the necessary mechanical resistance for the indication and the faculty to generate bone growth.

Organic MatrixPolylactic Acid

Organic MatrixPolylactic Acid

Mineral ChargeBiphasic Calcium Phosphate (BCP) Granules

Better balance between degradation and mechanical strength than PLGA or PLA 8, 9, 10

L-Lactide provides greater mechanical resistance

DL-Lactide is amorphous (the crystallinity has been removed) which increases the resorption rate

75% PLDLLAPromotes the scaffold effect for osteoconduction and osteogenesis during the resorption of the polymer by hydrolysis4

For bioactive ionic exchange: TCP dissolution and bony crystal precipitation. Newly bioactive interface with bone cells

Regeneration of architectural bone

25% MBCP™ Technology

* 30,000 cages

Mineral

BonePhase

Bioactivity

MB

CPmicroporositymacroporosity

calciumphosphate

biphasic

Instruments

Class III Medical Device According to EU Directive EEC/93/42

Consult instructions for use

Certain products may not be approved for sale in all countries

Osteotwin™ Product References

Screws7 mm 8 mm 9 mm 10 mm

20 mmComposite 11CPVI0720 11CPVI0820 11CPVI0920 -

Polylactic 13PVI0720 13PVI0820 13PVI0920 -

25 mmComposite 08CPVI0725 08CPVI0825 08CPVI0925 12CPVI1025

Polylactic 13PVI0725 13PVI0825 13PVI0925 13PVI1025

30 mmComposite 08CPVI0730 08CPVI0830 08CPVI0930 08CPVI1030

Polylactic 13PVI0730 13PVI0830 13PVI0930 13PVI1030

Length

Diameter

Screwdriver

Screwdriver Shaft 1

Screwdriver Shaft 2

Screwdriver Shaft 3

Nitinol Guide Wire

Rachet Handle

Tap Shaft

Tap

Dilator 07/08 - Screw

Dilator 09/10 - Screw

Dilator 07/08 - Sheath

Dialtor 09/10 - Sheath

Introductor 07/08 - Sheath

Introductor 09/10 - Sheath

Osteotwin Instrumentation Tray 14INBT001

Osteotwin Screw Instrumentation Tray 14INBT002

Osteotwin Sheath Instrumentation Tray 14INBT003

Empty Tray 14INBT004

Supplied sterile

ISO 13485

Osteoconductive Scaffold

75% PLDLLA & 25% BCP the ideal ratio between mechanical resistance and the faculty to generate bone growth.

Osteotwin™ ACL Fixation System

Affix Sheath

Affix is designed to provide soft tissue fixation in ACL reconstruction surgery. Using Affix guarantees superior fixation strength and greater graft protection.

Osteotwin™ Affix is a new and unique Tibial Fixation Device from Biomatlante.

Rotational locking system during screw insertion

Innovative & Expandable

Interior threading can be used with most screws on the market

Guide wire friendly

Self opening stabilization system

Easy & Safe

Ancillary

Osteotwin™

Osteotwin™ Tray

Sheath Instrumentation

Screw Modular System

Screw Monoblock System

Osteotwin™ Instrumentation

Ancillary

Torx Screwdriver

Torx Screwdriver — optimal distribution of forceThe mean failure torque for Osteotwin™ is 6 N.m, whereas other leading implants show a breakage rate of 5 and 5,3 N.m*.

Other Instruments

Starter Tap Tunnel Dilator Guide Wire

Osteotwin™ ACL Fixation System

Osteotwin™ LoopFemoral Fixation Plate with loop

Osteotwin™ Loop is your implant of choice used to secure soft tissue grafts to bone during cruciate ligament reconstruction. Combined with a traditional surgical technique, Osteotwin™ Loop implant provides strength and security.

Osteotwin™ Loop Intended for use in tendodesis procedures with soft tissue graft (arthroscopic or open techniques) during Anterior & Posterior Cruciate Ligaments, Medial & Lateral Collateral

Ligaments and Medial Patellofemoral Ligament for knee reconstruction.

Tightly woven and pre-stretched to remove creep prior to implantation

Product Benefits• Simple technique

• Inherent Rotational Moment (IRM) for

effective seating on femoral cortex

High resistance (608.9 N)

Pre-loaded with passing sutures

Integrated method to reposition the implant

Lenght

Osteotwin™ High Tibial Osteotomy

MBCP™ WedgesBioactive Osteotomy Wedges Bone Graft Substitute

MBCP™ Wedges are designed to precisely fit within the shape of the opened wedge correction. Made of MBCP™, the reference in osteoconductive bone graft substitute, they are a biphasic calcium phosphate made of 60% hydroxyapatite (HA) and 40% Beta-Tricalcium Phosphate (ß-TCP), allowing for simultaneous controlled adsorption and promotion of osteogenesis. While MBCP™ Wedges have a high compressive force of 10-12MPa, they are intended for use with rigid fixation systems.

Biomatlante recommends these HTO plate specialists:

Controlled resorbtion and

Custom design — Standard design

20 years of proven efficacy

Osteotwin™ References

1. Daculsi, G., O. Laboux, et al. (2003). «Current state of the art of biphasic calcium phosphate bioceramics.» Journal of Materials Science: Materials in Medicine 14(3): 195-200.

2. Middleton, J. C. et al.; Biomaterials 21 (23), «Synthetic biodegradable polymers as orthopedic devices», 2000 2335-2346.

3. Suchenski, M., M. B. McCarthy, et al. (2010). «Material Properties and Composi-tion of Soft-Tissue Fixation.» The Journal of Arthroscopic and Related Surgery 26(6): 821-831.

4. Uzel, A. P., E. Seris, et al. (2013). «Preclinical and clinical cases of new absor-bable composite interference screws in osteoarticular surgery.» Key Enginee-ring Materials 529-530: 325-330.

5. Kaeding, C., J. Farr, et al. (2005). «A Prospective Randomized Comparison of Bioabsorbable and Titanium Anterior Cruciate Ligament Interference Screws.» The Journal of Arthroscopic and Related Surgery 21(2): 147-151.

6. Hunt, J. A. and J. T. Callaghan (2008). «Polymer-hydroxyapatite composite versus polymer interference screws in anterior cruciate ligament reconstruction in a large animal model.» Knee Surgery, Sports Traumatology, Arthroscopy 16(7): 655-660.

7. Weiler, A., H. J. Windhagen, et al. (1998). «Biodegradable interference screw fixation exhibits pull-out force and stiffness similar to titanium screws.» The American journal of sports medicine 26(1): 119-126.

8. Weiler, A., R. F. Hoffmann, et al. (1998). «Hamstring tendon fixation using inter-ference screws: a biomechanical study in calf tibial bone.» Arthroscopy: The Journal of Arthroscopic and Related Surgery 14(1): 29-37.

9. Black, J., (1988). «Does corrosion matter?» The Journal of Bone and Joint Surgery, 70-B(4): 517-520.

10. Bauer, J., Turgay, E., et al. (2010)., «Torsional stability of interference screws derived from bovine bone - a biomechanical study.» BMC Musculoskeletal Disorders 11: 82

11. 1. Uzel, P. A., G. Daculsi, et al, «Utilisation des coins de MBCP™ en traumatologie lors des fractures enfoncement (tibia proximal et distal, calcanéum) : double intérêt de comblement et d’étayage», 13ème Congrès de l’AOLF (2012)

12. 2. R. Schouten, G. Hooper, The use of Bone substitute (Triosite) wedges in Medial Opening wedge high tibial osteotomies, 33 Patient clinical study, Journal of Bone & Joint Surgery, British Volume (2009)

13. 3. Rouvillain, J.L., Lavalle, F., Pascal-Mousselard, H., Catonne, Y., Daculsi, G., Clinical, radiological and histological evaluation of biphasic calcium phosphate bioceramic wedges filling medial high tibial valgisation osteotomies., Knee (2009)

14. 4. Rouvillain, J. L., Pascal-Mousselard, H., Lavalle, F, Garron E., Catonné Y., Daculsi G., MBCP Wedges performance during open medial tibial osteotomy, European conference on biomaterials (2006)

15. 5. Lavallé, F., H. Pascal-Mousselard, et al, Biphasic ceramic wedge and plate fixation with locked adjustable screws for open wedge tibial osteotomy, Revue de chirurgie orthopédique (2004)

* Data on files, Biomatlante

Backed by 20 years of experience in the development and manufacturing of synthetic bone substitutes, Biomatlante readily meets the challenge of constantly evolving its product line to meet today’s market demands for new, more effective, generations of biomaterials and smart scaffolds for tissue regeneration and minimally invasive surgical technologies.

Biomatlante

Commitment We are committed to our industry – we feel we have a bond with physicians and patients alike.

Our Values

Integrity We treat people fairly and expect the same in return.

Quality We are committed to providing products of the highest quality – We never compromise!

PassionWe love what we do. Innovative bone regeneration solutions are truly our passion.

ISO 13485Read the instructions for use

BIOMATLANTE5 rue Édouard Belin

Z.A. Les Quatre Nations44360 Vigneux-de-Bretagne

France

+33 (0)2 28 02 00 [email protected]

www.biomatlante.com

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