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Synthes is a leading globalmedical device company.

We develop, produce andmarket instruments, implantsand biomaterials for the surgical fixation, correctionand regeneration of the human skeleton and its soft tissues.

Dentoalveolar Product Catalog.Office-based products.

Synthes 1

Introduction

Product Information

Table of Contents

Company Overview 2

Hard Tissue Regeneration: 3Demineralized and mineralized bone

Soft Tissue Regeneration: Dermamatrix Acellular Dermis 5

Synthetic Bone Graft Substitute: chronOS Granules 6and Preforms

Temporary Anchorage Devices: 7Orthodontic Bone Anchor System

Bone Fixation: BoX System 9

Distraction Osteogenesis: Alveolar Distractor Set 12

Bone Graft Containment: 14RapidSorb Rapid Resorbable Fixation System

Company Overview

2 Synthes Dentoalveolar Product Catalog

SynthesQuality and consistent customer orientationSynthes is committed to designing, developing and delivering products and services that meet or exceed our customers' needs. Our goal is to provide high quality, constant innovation and a complete focus on the needs of our customers, by continuously developing better solutions.

Product portfolioSynthes is an established leader in the medical device industry. The product portfolio for office-based dentoalveolarsurgery consists of surgical implants for bone fixation, bonegraft containment and skeletal anchorage, as well as a broadbiomaterials platform. Additional products are availablethrough Synthes CMF.

For more information, contact your local Sales Consultant,our Dentoalveolar Surgery Products Reference Line at (800)824-2020, or e-mail: [email protected]. Please refer toproduct inserts and other product support materials for moreinformation on contraindications.

For instruments and metallic implantsNote: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer tohttp://us.synthes.com/Medical+Community/Cleaning+and+Sterilization.htmor to the below listed inserts, which will be included in the shipping container:– Processing Synthes Reusable Medical Devices—Instruments, Instrument Trays

and Graphic Cases—DJ1305– Processing Non-sterile Synthes Implants—DJ1304

The allograft tissue forms available through Synthes areprocessed by the Musculoskeletal Transplant Foundation(MTF). MTF’s standards are set by a Medical Board ofTrustees composed of more than 40 surgeons from world-renowned academic institutions. MTF has maintained an exemplary safety record since their inception in 1987—having distributed almost 4.2 million allografts from nearly80,000 donors.

Hard Tissue Regeneration

Demineralized boneDemineralized bone is osteoconductive and has osteoinductivepotential*. DBM Putty is donor bone that is demineralizedand then combined with sodium hyaluronate, a naturally derived material that is biocompatible and biodegradable.DBM Putty has a high demineralized bone content to maximize the amount of bone placed at the surgical site.DBM Putty is intended for the augmentation of deficientmaxillary and mandibular alveolar ridges and the treatmentof oral/maxillofacial and dental intraosseous defects.

Mineralized boneMineralized bone does not undergo the mineral removalprocess, leaving the mineral component of the donor bone intact.

Synthes 3

Product Information

* It is unknown how the osteoinductive potential, measured in the athymic mouse model or the alkaline phosphatase assay, will correlate with clinical performance in human subjects.


Hard Tissue Regeneration continued

PowdersDemineralized Cortical Powder

Volume020075 0.25 cc020076 0.5 cc020077 1.0 cc020078 3.0 cc

Mineralized Cortical Powder

Volume020175 0.25 cc020176 0.5 cc020177 1.0 cc020178 3.0 cc

Mineralized Cancellous Powder

Volume020172 0.5 cc020173 1.0 cc020174 2.5 cc

GranulesDemineralized Cortical/ Cancellous Granules

Volume020038 0.5 cc020039 1.0 cc

Mineralized Cortical/ Cancellous Granules

Volume020191 0.5 cc

020192 1.0 cc

PuttyDBM Putty

Volume030005 0.5 cc030010 1.0 cc030025 2.5 cc

Product Information

Synthes 5

Soft Tissue Regeneration

DermaMatrix Acellular DermisDermaMatrix Acellular Dermis is a tissue derived from donated human skin, and processed by MTF, that can beused for the replacement, repair, or reinforcement of soft tissue defects. Use of DermaMatrix eliminates the need for a secondary surgical procedure. Key features includerapid rehydration, three-year shelf life, and no required refrigeration. DermaMatrix can be used for root coverage,soft tissue ridge augmentation, free gingival grafts, guidedbone regeneration, vestibuloplasty, and oral cavity repair.

Thin tissueSize (cm) Thickness (mm)

010101 1 x 1 0.4–0.8010102 1 x 2 0.4–0.8010104 1 x 4 0.4–0.8010202 2 x 2 0.4–0.8010204 2 x 4 0.4–0.8

Thick tissueSize (cm) Thickness (mm)

011101 1 x 1 0.8–1.7011102 1 x 2 0.8–1.7011104 1 x 4 0.8–1.7011204 2 x 4 0.8–1.7

Synthetic Bone Graft Substitute

chronOS Granules and PreformschronOS granules and preforms are synthetic, osteoconduc-tive, β-tricalcium phosphate bone void fillers that can beused to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region. The porosity, interconnection of macropores, and presence of microporesof chronOS provide an ideal scaffold for bony infiltration. The compressive strength of chronOS is 5 MPa, similar tothat of human cancellous bone. chronOS is replaced withbone in 6–18 months.

chronOS β–Tricalcium Phosphate Granules, sterile

710.000.98S Extra small 0.5 mm–0.7 mm 0.5 cc710.001.98S Small 0.7 mm–1.4 mm 0.5 cc710.002.98S Small 0.7 mm–1.4 mm 1.0 cc710.003.98S Small 0.7 mm–1.4 mm 2.5 cc710.011.98S Medium 1.4 mm–2.8 mm 2.5 cc710.014.98S Medium 1.4 mm–2.8 mm 5.0 cc

chronOS β–Tricalcium Phosphate Blocks, sterile

710.042.98S 5 mm x 5 mm x 10 mm710.047.98S 20 mm x 20 mm x 10 mm

chronOS β–Tricalcium Phosphate Wedges, sterile

710.050.98S Rectangular 6.5 mm x 25 mm x 20 mm 10°angle710.057.98S Semi-circular 7 mm x 25 mm x 35 mm 7°angle


Product Information

Synthes 7

Temporary Anchorage Devices

Orthodontic Bone Anchor SystemThe Orthodontic Bone Anchor System consists of plate anchors and screw anchors. The anchors are intended to be implanted intraorally and used for orthodontic procedures.

Orthodontic bone anchors provide fixed skeletal anchoragefor improved control of tooth movement includingintrusion/extrusion of teeth, distal/mesial movement of teeth, and space closure. Using skeletal anchorage can eliminate the need for external anchorage (such as head gear).

Set01.500.006 Orthodontic Bone Anchor (OBA) Set

includes products listed

Module60.500.006 Module for Orthodontic Bone Anchor

(OBA) System60.500.007 Label Sheet, Orthodontic Bone Anchor

See next page for individual implants.


Product Information

Temporary Anchorage DevicesOrthodontic Bone Anchor (OBA) Set continued

ImplantsTitanium OBA Screw Anchor

04.500.006 6 mm, self-drilling04.500.008 8 mm, self-drilling04.500.010 10 mm, self-tapping

Titanium OBA Plate Anchors04.500.014 Mesh Pad, 4 hole04.500.017 Mesh Pad, 5 hole04.500.012 Bracket, 4 hole04.500.015 Bracket, 5 hole04.500.013 Domed, 4 hole04.500.016 Domed, 5 hole

Titanium OBA Plate Anchor Screws, self-drilling (5/pkg.)

04.500.024.05 4 mm 04.500.026.05 6 mm 04.500.028.05 8 mm

Titanium OBA Emergency Screws (1/pkg.)04.500.034.01 4 mm 04.500.036.01 6 mm 04.500.038.01 8 mm

Instruments03.500.001 Screw Anchor Cruciform Screwdriver Blade

with Spring Holding Sleeve, short03.503.202 MatrixMIDFACE Screwdriver Blade,

hex coupling, self-retaining, 76 mm311.007 Screwdriver Handle with hex coupling, large329.14 Universal Bending Pliers,

for 1.0 mm–2.0 mm plates391.98 Plate Cutter,

for 1.0 mm–2.0 mm plates

1.25 mm Drill Bits, J-latch, 44.5 mm03.500.004 4 mm stop03.500.006 6 mm stop03.500.008 8 mm stop03.500.010 10 mm stop

Screw anchor

Plate anchor screw

4-hole mesh plate anchor

4-hole bracket plate anchor

4-hole domed plate anchor

5-hole mesh plate anchor

5-hole bracket plate anchor

5-hole domed plate anchor

Synthes 9

Bone Fixation

BoX SystemSynthes BoX System for bone fixation is a compact and versatile module that can be filled with a variety of bone fixation plates and screws to suit individual needs. Inserts are available in 1.3 mm, 1.5 mm and 2.0 mm screw sizes.The TwinBoX system can accommodate two screw systemssimultaneously along with small instruments underneath the inserts.

ModulesTwinBox Module with Lid and Inserts

60.503.002 1.3 mm/1.5 mm

60.503.003 1.3 mm/2.0 mm

60.503.004 1.5 mm/2.0 mm

BoX Module with Lid and Insert

60.503.050 1.3 mm

60.503.060 1.5 mm

See next page for individual implants.

Product Information


Bone FixationBoX System continued

Instruments311.005 Screwdriver Handle, with hex coupling, small 313.805 1.3 mm Screwdriver Blade, self-retaining,

PlusDrive, 52 mm (for 1.3 mm system)313.254 1.5 mm/2.0 mm Screwdriver Blade,

self-retaining, PlusDrive, 52 mm (for 1.5 mm and 2.0 mm systems)

347.964 Combination Bending Pliers, for 1.0 mm–2.0 mm plates

391.965 Combination Bending/Cutting Pliers, for 1.0 mm–2.0 mm plates

Drill Bits, Stryker J-latch316.235 1.0 mm, 60 mm long (for 1.3 mm system)

317.235 1.1 mm, 65 mm long (for 1.5 mm system)


Drill Bits, mini quick coupling




Implants1.3 mm Titanium Cortex Screws, self-tapping, PlusDrive (5/pkg.)

Length (mm) Length (mm)400.436 6 400.442 12400.438 8 400.444 14400.440 10 400.446 16

1.3 mm Titanium Cortex Screws, self-drilling, PlusDrive (5/pkg.)

Length (mm) Length (mm)400.453 3 400.455 5400.454 4 400.456 6

1.5 mm Titanium Cortex Screws, self-tapping, PlusDrive (5/pkg.)

Length (mm) Length (mm)400.036 6 400.042 12400.038 8 400.044 14400.040 10 400.046 16

1.5 mm Titanium Cortex Screws, self-drilling, PlusDrive (5/pkg.)


1.7 mm Titanium Emergency Screws (5/pkg.)Length (mm) Length (mm)

400.484 4 400.490 10400.485 5 400.492 12400.486 6 400.494 14400.488 8 400.496 16

2.0 mm Titanium Cortex Screws, self-tapping, PlusDrive (5/pkg.)

Length (mm) Length (mm)401.043 6 401.046* 12401.044 8 401.047* 14401.045* 10 401.048* 16

2.0 mm Titanium Cortex Screws, self-drilling PlusDrive (5/pkg.)


* Coarse pitch

Synthes 11

2.0 mm Titanium Emergency Screws (5/pkg.)Length (mm) Length (mm)

400.274 4 400.280 10400.275 5 400.282 12400.276 6 400.284 14400.278 8 400.286 16

2.4 mm Titanium Emergency Screws (5/pkg.)

Length (mm) Length (mm)401.791 5 401.796 12401.792 6 401.797 14401.794 8 401.798 16401.795 10

Titanium Adaption Plates (5/pkg.)

Thickness Length(mm) Holes (mm)

421.010 1.3 24 95446.10 1.5 20 90447.10 2.0 20 100

Additional implants and sizes available

Distraction Osteogenesis

Alveolar Distractor SetThe Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required. Indications include deficiency as a result of trauma, resorption after dental extraction, periodontal disease, tumor resection and congenital deformity.

The Alveolar Distractor has an angulation mechanism that facilitates intraoperative manipulation of the direction of distraction up to 52° toward the buccal and 32° toward the lingual side.

Set01.500.804 Alveolar Distractor Set

includes products listed

Module and Instrument Trays685.000 Module for Alveolar Ridge Distractor304.686 Instrument Tray, Universal304.687 Instrument Tray Lid, Universal

Screw Length Markers, for self-drilling screws304.104W 4 mm304.106W 6 mm304.108W 8 mm

Product Information


16 mm8 mm 12 mm

Three distraction lengthsThree implant sizes allow 8 mm, 12 mm and 16 mm of distraction:

This choice offers the flexibility to fit the distractor to differentanatomical conditions.

Synthes 13

ImplantsTitanium Alveolar Ridge Distractors, with straight plate

488.074 8 mm488.075 12 mm488.076 16 mm

1.5 mm Titanium Cortex Screws, self-drilling, with PlusDrive recess (5/pkg.)

400.054 4 mm400.056 6 mm400.058 8 mm

2.0 mm Titanium Emergency Screws, with PlusDrive recess (5/pkg.)

400.274 4 mm400.276 6 mm400.278 8 mm

Instruments311.005 Screwdriver Handle, with hex coupling,

small313.253 1.5 mm/2.0 mm Screwdriver Blade,

self-retaining, PlusDrive, hex coupling, 76 mm

314.001 Activation Instrument, for Alveolar Distractor314.003 Activation Instrument with Joint,

for Alveolar Distractor314.004 Angular Adjustment Instrument,

for Alveolar Distractor, hex coupling314.651 1.5 mm Cruciform Screwdriver Blade with

Spring Holding Sleeve, short, hex coupling

1.1 mm Drill Bits, Stryker J-latch317.14 4 mm stop, 44.5 mm317.16 6 mm stop, 44.5 mm317.18 8 mm stop, 44.5 mm317.235 (without stop), 65 mm

347.964 Combination Bending Pliers, for 1.0 mm–2.0 mm plates

391.965 Combination Bending/Cutting Pliers, for 1.0 mm–2.0 mm plates

391.98 Plate Cutter, for 1.0 mm–2.0 mm plates


Product Information

Bone Graft Containment

RapidSorb Rapid Resorbable Fixation SystemThe RapidSorb Rapid Resorbable Fixation System can be used for bone graft containment in the maxilla or mandibleand can be cut and contoured in a hot water bath to fit the bony anatomy.

RapidSorb implants are manufactured from 85:15 poly(L-lactide-co-glycolide) copolymer. This material retains85% of its bending strength at 8 weeks, and completely resorbs at 12 months.

Screws

Tack

Instrument Tray and Accessories305.806 Small Instrument Tray Lid, for Resorbable

Fixation System305.807 Small Instrument Tray Base, for Resorbable

Fixation System305.811 Instrument Insert, for Resorbable

Instrument Trays530.510 Water Bath Heater530.512 Water Bath Tray530.514 Water Bath Sterility Cover

Implants1.5 mm Rapid Resorbable Cortex Screws, sterile, 2/pkg.

805.603.02S 3 mm805.604.02S 4 mm805.605.02S 5 mm805.606.02S 6 mm805.608.02S 8 mm

805.614.02S 1.5 mm Rapid Resorbable Tack, 4 mm,sterile, 2/pkg.

2.0 mm Rapid Resorbable Cortex Screws, sterile, 2/pkg.

806.004.02S 4 mm806.006.02S 6 mm806.008.02S 8 mm

1.5 mm Rapid Resorbable Contourable Mesh Plates, sterile

851.611.01S 50 mm x 50 mm, 0.25 mm thick851.612.01S 100 mm x 100 mm, 0.25 mm thick851.621.01S 50 mm x 50 mm, 0.5 mm thick851.622.01S 100 mm x 100 mm, 0.5 mm thick851.651.01S 50 mm diameter, 0.5 mm thick851.652.01S 100 mm diameter, 0.5 mm thick851.661.01S 50 mm diameter, 0.8 mm thick

Synthes 15

Instruments310.177 1.5 mm Drill Bit, with 4 mm stop, Stryker

J-latch, 45 mm, for Resorbable Tacks311.005 Screwdriver Handle, with hex coupling, small311.060.01S– Self-Drilling Taps, hex coupling, sterile311.073.01S314.415 1.5 mm Tack Driver with Holding Sleeve314.423 Automated Tack Driver314.425 1.5 mm Cruciform Screwdriver Blade, with

Spring Holding Sleeve, hex coupling317.64– 1.5 mm Drill Bits, Stryker J-latch, 44.5 mm,317.68 4 mm–8 mm stops329.481 Bending Template, for 1.5 mm/2.0 mm

Resorbable Mesh Plates391.964 Scissors for Resorbable Mesh Plates

Synthes CMF1302 Wrights Lane EastWest Chester, PA 19380Telephone: (610) 719-5000To order: (800) 523-0322Fax: (610) 251-9056

For MTF product: To order (800) 522-9069Fax: (877) 534-1560

www.synthesdento.com

© 2010 Synthes, Inc. or its affiliates. All rights reserved. DermaMatrix, PlusDrive, RapidSorb and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 4/10 J9789-AMTF is a registered trademark of the Musculoskeletal Transplant Foundation.

Musculoskeletal Transplant Foundation125 May StreetEdison, NJ 08837P: (732) 661-0202F: (732) 661-2298

dentoalveolar product catalogsynthes.vo.llnwd.net/o16/llnwmb8/us mobile/synthes north...company...

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