Craniofacial Instrument and Module Systemssynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North...

Craniofacial Instrument and ModuleSystems. Complete selection ofinstruments and cases.

Modular system forcomplete selectionof implants andinstruments

Implant modulessupported by a set of universalinstruments

Color-coded modules and instruments

Introduction

Product Information

Table of Contents

Synthes

AO Principles 2

Craniofacial Instrument and Module Systems 3

1.0 mm Module 4

1.3 mm Module 6

1.5 mm Module 8

2.0 mm Module 10

Craniofacial Graphic Cases (690.652 and 690.654) 12

Instrument Insert Trays (for 690.652 and 690.654) 13

Craniofacial Graphic Cases (690.005 and 690.601) 17

Cruciform and PlusDrive Screws 19

2 Synthes Craniofacial Instrument and Module Systems

AO Principles

In 1958, the AO formulated four basic principles which havebecome the guidelines for internal fixation.1

Anatomic reductionThe craniofacial plates are available in a wide variety of shapesand sizes. All plates can be contoured to allow reduction ofcraniofacial fractures.

Stable fixationMultiple screw sizes and a range of plate strengths allow thesurgeon to choose the construct which will provide appropriatestability for a particular fracture.

Preservation of blood supplyCompact plate design minimizes the need to strip the periosteum, thereby maintaining the blood supply to the bone.

Early, active mobilizationPlate and screw features combined with AO technique createan environment for bone healing, facilitating the return tooptimal function.

1. M. E. Müller, M. Allgöwer, R. Schneider, and H. Willenegger. Manual of Internal Fixation, 3rd Edition. Berlin: Springer-Verlag. 1991.

Craniofacial Instrument and Module Systems (690.652 and 690.654)

Synthes 3

FeaturesComplete modularity—choose modules according to your needs:– 1.0 mm, 1.3 mm, 1.5 mm, 2.0 mm

– Mesh

– Orthognathic Plate

– Orthognathic Pre-Bent Plate

– Orthognathic Screw

– Self-Drilling Screw

Two- or four-module craniofacial graphic cases are available: – Two-module (690.652)

– Four-module (690.654)

Implant modules are supported by a set of universal instruments stored in removable trays.

All modules and product labeling are color-coded accordingto screw size for easy identification.1.0 mm = Green1.3 mm = Gold1.5 mm = Red2.0 mm = Blue

Screw length markers are used to customize each module by preferred screw type and lengths: choose self-drilling or self-tapping, length and quantity.

BenefitsHospitals can build a system for specific requirements and easily expand the system as their needs change.

Modules hold a full complement of implants, permitting multiple surgeries without restocking.

Simplifies intraoperative use when combining multiple implant sizes.

Replaces multiple implant systems, thereby reducing hospital inventory.

Note: 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

1.0 mm Module

Module will hold*:– Drill Bits with stop (12)

– Screwdriver Blades (2)

– Screws (170)

– Emergency Screws (34)

Module, Markers and Labels304.663 1.0 mm Module

304.102W, Screw Length Markers, for self-drilling screws,

304.103W (white, 2 mm –3 mm)

306.663 1.0 mm Screw Length Marker Kit (black, 2 mm –8 mm)

304.663P Label Sheet for 1.0 mm Craniofacial Module

304.700S1 Label Sheet for Maxillofacial Screws

304.700S2 Label Sheet for Maxillofacial Screwdriver Blades

Instruments0.70 mm Drill Bits

316.03 Universal /Hall coupling, 3 mm stop

316.13 Stryker J-latch coupling, 3 mm stop

316.23 Mini quick coupling, 3 mm stop

0.76 mm Drill Bits











* Contents not included, must be ordered separately.

Indications

1.0 mm Titanium T-Plates

420.70 5 holes base x 5 holes shaft

420.71 5 holes base x 7 holes shaft

1.0 mm Titanium H-Plates

420.84 3 holes each side x 0 holes bridge

420.85 5 holes each side x 1 hole bridge

1.0 mm Titanium Plates

420.10 Adaption Plate, 100 mm length, 34 holes

420.21 Orbital Rim Plate, 11 holes

420.81 X-Plate, 5 holes

Implants1.0 mm Titanium Mesh Plates

420.00 29 mm x 40 mm, 4.5 mm x 5 mm holespacing, 0.5 mm thickness

420.02 38 mm x 42 mm, 4 mm x 4 mm holespacing, 0.4 mm thickness



420.070 Mesh Screen, 100 mm x 100 mm, 0.1 mm thickness

1.0 mm/1.5 mm Titanium Mesh Plate

420.071 100 mm x 100 mm, 4 mm hole spacing

1.0 mm Titanium Strut Plates

420.01 30 mm length, 16 holes


1.0 mm Titanium Orbital Mesh Plates◊

420.302 0.2 mm thick

420.303 0.3 mm thick

420.304 0.4 mm thick

1.0 mm Titanium Orbital Floor Plates◊

420.40 Universal

420.401 Anatomic, small

420.402 Anatomic, large

420.403 Anatomic, medium

1.0 mm Titanium Medial Wall Plates◊

420.44 Left

420.45 Right

1.0 mm Titanium L-Plates

420.54 4 holes base x 5 holes shaft, left

420.55 4 holes base x 5 holes shaft, right

1.0 mm Titanium Y-Plates

420.62 2 holes each arm x 5 holes shaft


420.68 Double, 1 hole each arm x 2 holes shaft

Synthes 5

◊ These implants are available nonsterile or sterile-packed. Add “S” to catalog number for sterile product.

1.3 mm Module

Module will hold*:– Drill Bits with stop (12)– Screwdriver Blades (4)– Screws (170)– Emergency Screws (34)

Module, Markers and Labels304.672 1.3 mm Module304.103W– Screw Length Markers, for self-drilling screws,

304.108W (white, 3 mm–8 mm)

306.666 1.3 mm Screw Length Marker Kit (black, 3 mm–6 mm and 8 mm)

304.672P Label Sheet for 1.3 mm Craniofacial Module













Implants1.3 mm Titanium Mesh Plates



421.099 Mesh Screen, 100 mm x 100 mm, 0.2 mm thickness

1.3 mm Titanium Orbital Floor Plates◊

421.040 Universal

421.043 Anatomic, medium

421.048 Anatomic, small

421.049 Anatomic, large


Indications

* Contents not included, must be ordered separately.◊ These implants are available nonsterile or sterile-packed.

Add “S” to catalog number for sterile product.

1.3 mm Titanium Box Plates

421.095 13 mm x 8 mm, 4 holes

421.096 13 mm x 13 mm, 4 holes

1.3 mm Titanium Orbital Mesh Plates◊

421.302 0.2 mm thick

421.303 0.3 mm thick

421.304 0.4 mm thick

1.3 mm Titanium Plates

421.010 Adaption Plate, 95 mm length, 24 holes

421.021 Orbital Rim Plate, 9 holes, 35 mm length

421.071 T-Plate, 3 holes base x 4 holes shaft

421.080 Strut Plate, 43 mm length, 18 holes, 5 mm hole spacing

421.081 X-Plate, 4 holes

421.085 H-Plate, 5 holes in each side, 1 hole bridge

Implants continued1.3 mm Titanium Medial Wall Plates

421.044 Left

421.045 Right

1.3 mm Titanium Oblique L-Plates

421.050 3 x 3 holes, left

421.051 3 x 3 holes, right




421.061 1 hole each arm x 3 holes shaft

421.067 Double, 1 hole each arm x 2 holes shaft, 22 mm



1.3 mm Titanium Contourable Mesh Plates,malleable◊

421.004 38 mm x 45 mm

421.007 100 mm x 100 mm

421.015 30 mm diameter



1.3 mm Titanium Contourable Mesh Plates,rigid◊

421.005 38 mm x 45 mm

421.008 100 mm x 100 mm

421.009 200 mm x 200 mm




Synthes 7


1.5 mm Module



– Screws (190)


Module304.661 1.5 mm Module

304.104W– Screw Length Markers, for self-drilling screws,304.108W (white, 4 mm–8 mm)

306.661 1.5 mm Screw Length Marker Kit (black, 4 mm–12 mm, 2 mm increments)

304.661.29 Label Sheet for 1.5 mm Craniofacial Module
















Implants1.5 mm Titanium Orbital Rim Plates

446.18 8 holes, 34 mm

446.20 10 holes, 41 mm

446.22 12 holes, 49 mm

446.538 Malleable, 8 holes, 34 mm




*Contents not included, must be ordered separately.

Indications

1.5 mm Titanium Contourable Mesh Plates,malleable◊

446.014 38 mm x 45 mm

446.017 100 mm x 100 mm




1.5 mm Titanium Contourable Mesh Plates,rigid◊

446.015 38 mm x 45 mm

446.018 100 mm x 100 mm

446.019 200 mm x 200 mm




1.5 mm Titanium Box Plates

446.096 14 mm x 14 mm, 4 holes

446.097 16 mm x 16 mm, 4 holes

446.916 16 mm x 10 mm, 4 holes

1.5 mm Titanium Adaption Plates


446.101 Low Profile, 90 mm length, 20 holes

450.101 Malleable, 90 mm length, 20 holes

Implants continued1.5 mm Titanium Oblique L-Plates





1.5 mm Titanium L-Plates, malleable







446.611 Low profile, 1 hole each arm x 3 holes shaft



450.611 Malleable, 1 hole each arm x 3 holes shaft

1.5 mm Titanium X-Plates

446.81 4 holes

446.811 Low profile, 4 holes

1.5 mm Titanium Orbital Floor Plate◊

446.40 Universal

1.5 mm Titanium Medial Wall Plates◊

446.44 Left

446.45 Right

Synthes 9


2.0 mm Module



– Screws (140)


Module304.662 2.0 mm Module

304.104W– Screw Length Markers, for self-drilling screws,

304.108W (white, 4 mm–8 mm)

306.662 2.0 mm Screw Length Marker Kit (black, 4 mm–18 mm, 2 mm increments)

304.662.29 Label Sheet for 2.0 mm Craniofacial Module

















Indications

*Contents not included, must be ordered separately.

Implants2.0 mm Titanium Oblique L-Plates







2.0 mm Titanium L-Plates, malleable








447.630 Malleable, 2 holes each arm x 3 holes shaft(110°)

447.68 Double, 2 holes each arm


451.611 Malleable, 1 hole each arm x 3 holes shaft

2.0 mm Titanium X-Plate

447.81 4 holes

2.0 mm Titanium H-Plates

447.85 2 holes each arm x 1 hole bridge

447.86 2 holes each arm x 0 hole bridge

2.0 mm Titanium Zygomatic Plates (DCP)

443.44 4 holes, 22 mm length



Synthes 11

2.0 mm Titanium Adaption Plates


447.38 With broad hole spacing, 193 mm length, 30 holes

449.021 Double, 100 mm length, 2 x 20 holes

451.101 Malleable, 100 mm length, 20 holes

2.0 mm Titanium Orbital Rim Plates




Craniofacial Graphic Cases (690.652 and 690.654)

Graphic Cases690.652 Craniofacial Graphic Case, with storage

for two modules

690.654 Craniofacial Graphic Case, with storage for four modules

Sample set configurations for 690.652 and 690.654

Note: Graphic case holds one Basic Craniofacial Insert Trayand two additional insert trays.

– Basic Craniofacial Insert Tray (690.625)

– Craniofacial Supplement Insert Tray (690.651)

– Orthognathic Trocar Insert Tray (690.657)


690.652

690.654

Instrument Insert Trays (for 690.652 and 690.654)

Synthes 13

Ratcheting Screwdriver Insert Tray (690.629) This tray is designed to hold:

– Ratcheting Screwdriver Handles (holds 2)

– Ratcheting Screwdriver Handle, one piece (311.023)

– Ratcheting Screwdriver Body (311.014) with Small Handle(311.016) or Large Handle (311.017)

– Holding Sleeve (313.97)

– Screwdriver Blades with hex coupling (2 slots—each slot will hold 2)

– 1.5 mm blades

– 2.0 mm blades

– 2.4 mm blades

Basic Craniofacial Insert Tray (690.625)This tray is designed to hold:

– Plate Cutter (391.98)

– Mesh Cutter (391.952)

– Combination Bending Cutter /Cutting Pliers (391.965)

– Combination Bending Pliers (347.964)

– Screwdriver Handles (311.005), (311.006) (holds 2)

– T-Handle (03.507.000)

– 3.5 mm Threaded Reduction Tool (03.507.003)

– Drill Bits (holds 4)

– Plate Holding Forceps (347.98)

Note: The metal bracket for the T-Handle ships with the instrument tray and must be secured before use.

Note: Unless otherwise noted, trays will hold one of each indicated item.

IMF Screw Compact Insert Tray (690.631) This tray is designed to hold:

– Precut cerclage wire (holds 20)

– 0.5 mm (291.230.98)

– 0.6 mm (291.240.98)

– 1.5 mm Drill Bits, with 12 mm stop (holds 2)

– 2.4 mm/3.0 mm Cruciform Screwdriver Blade, hex coupling (313.939)

– Holding Sleeve (313.97)

– 2.0 mm IMF Screws, self-drilling

– 8 mm (201.928) (holds 15)

– 12 mm (201.932) (holds 15)

Craniofacial Supplement Insert Tray (690.651)This tray is designed to hold:

– Plate Holding Instruments (347.986), (347.987) (holds 2)

OR

– Plate Holding Forceps, locking (399.001)

AND

– Screwdriver Handles (311.005), (311.006) (holds 2)

– Screwdriver Blades (holds 8)

Note: Tray comes preconfigured to hold cruciform and/or PlusDrive blades. Additional brackets are provided for installation of holding sleeve blades.



Synthes 15

Orthognathic Trocar Insert Tray (690.657)This tray is designed to hold:– Universal Trocar Handle (397.211)

– 2.0 mm Cheek Retractor Ring (397.43)

– Malleable C-Retractor (397.232)

– 2.0 mm Cheek Retractor Blade (397.42)

– 2.0 mm Cannula and Obturator (397.213)

– 1.5 mm (blue) Drill Guide (397.216)

– Depth Gauge (319.007)

– Standard Drill Bits (holds 3)

– Trocar Drill Bits (holds 3)

Note: Lid and brackets (not shown) can be removed if not needed.

Basic Trocar Insert Tray (690.644) This tray is designed to hold:

– Cheek Retractor Ring (03.506.002)

– 1.5 mm/1.8 mm/2.4 mm Drill Guide (03.506.004)

– 1.5 mm Threaded Drill Guide (312.158)

– 1.5 mm/1.8 mm Insert Drill Guide (312.172)

– 1.8 mm/2.4 mm Threaded Drill Guide (312.173)

– Drill Bits, with Stryker J-latch

– 1.5 mm (312.157)

– 1.8 mm (397.283)

– 2.4 mm (397.284)

– Cannula and Obturator (397.208 )

– Universal Trocar Handle (397.211)

– 2.4 mm Cheek Retractor Blade (397.22)

– Malleable C-Retractor (397.232)



Auxiliary Insert Tray (690.638)This tray is designed to function as an auxiliary bin. It is anempty tray with a mat.

Lid, for quarter-size insert trays (690.640)The lid allows individual insert trays to be stored separatelyoutside of the set, while keeping the items in the tray securelycovered. The translucent lid allows contents of the tray to be seen.

Synthes 17


Graphic Cases690.005 Craniofacial Modular Fixation System

Graphic Case, with storage for 4 modules

690.601 Craniofacial Modular Fixation System Graphic Case, with storage for 2 modules

Instrument Trays (for 690.601 and 690.005)The four chosen implant modules are supported by a set ofuniversal instruments stored in lightweight, removable trays.

Craniofacial Graphic Cases accommodate one full size instrument tray. Order tray and instruments separately.

690.008 Standard Instrument Tray, for CraniofacialModular Fixation System

690.611 Instrument/Trocar Tray, for Modular FixationSystems

690.011S1 Label Sheet for Instrument Trays

304.700S2 Label Sheet for Maxillofacial ScrewdriverBlades

InstrumentsScrewdriver Handles, mini quick coupling

311.03 Small

311.01.98 Large

Screwdriver Handles, hex coupling

311.005 Small

311.006 Medium

Ratcheting Screwdriver and Handles, hex coupling

311.014 Ratcheting Screwdriver Body

311.016 Small Handle, for 311.014

311.017 Large Handle, for 311.014

311.023 Ratcheting Screwdriver Handle

Contents not included, must be ordered separately.For screwdriver blades, see page 19 to 21.


Instruments continuedPlate Holding Forceps

347.98 For 1.0 mm–2.4 mm plates

348.98 Locking, for 1.0 mm and 1.3 mm plates

399.001 Locking, for 1.5 mm and 2.0 mm plates

Benders and Cutters

329.14 Universal Bending Pliers, for 1.0 mm–2.0 mmplates

347.962 Right Angle Bender, for 1.0 mm–2.0 mmplates

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

391.952 Mesh Cutter, for 1.0 mm–1.3 mm meshplates

391.98 Plate Cutter, for 1.0 mm–2.0 mm plates

Taps, quick coupling

311.15 For 1.5 mm Cortex Screws


311.206 For 2.0 mm Coarse Pitch Screws

311.21.98 For 2.0 mm Cortex Screws, long

Taps, hex coupling

311.209 For 2.0 mm Coarse Pitch Screws


Drill Bits (Refer to Synthes CMF Catalog for complete listing.)

Trocar SystemsUniversal Trocar System:

397.211 Universal Trocar Handle

397.232 Malleable C-Retractor

(2.0 mm Accessories)

397.213 2.0 mm Cannula and Obturator

397.216 1.5 mm Drill Guide

397.42 2.0 mm Cheek Retractor Blade

397.43 2.0 mm Cheek Retractor Ring


Trocar Systems continued(2.4 mm Accessories)

397.212 2.4 mm Cannula and Obturator

397.262 1.8 mm Drill Guide

397.22 2.4 mm Cheek Retractor Blade

397.23 2.4 mm Cheek Retractor Ring

Basic Trocar System:

03.506.002 Cheek Retractor Ring

03.506.003 Cheek Retractor Forceps

03.506.004 1.5 mm/1.8 mm/2.4 mm Drill Guide

312.158 1.5 mm Threaded Drill Guide

312.172 1.5 mm/1.8 mm Insert Drill Guide

312.173 1.8 mm/2.4 mm Threaded Drill Guide

Drill Bits, with Stryker J-latch

312.157 1.5 mm

397.283 1.8 mm

397.284 2.4 mm

397.208 Cannula and Obturator

397.211 Universal Trocar Handle

Cruciform and PlusDrive Screws

Synthes 19

1.0 mm Screws with Cruciform Recess400.502– 1.0 mm Titanium Cortex Screws, self-tapping,400.514 with cruciform recess, 2 mm–12 mm, 14 mm

400.602– 1.2 mm Titanium Emergency Screws, with400.614 cruciform recess, 2 mm–12 mm, 14 mm

1.3 mm Screws with Cruciform Recess400.623– 1.3 mm Titanium Cortex Screws, self-tapping,400.638 with cruciform recess, 3 mm–12 mm, 14 mm,

16 mm, 18 mm

400.653– 1.7 mm Titanium Emergency Screws, with400.668 cruciform recess, 3 mm–12 mm, 14 mm,

16 mm, 18 mm

1.5 mm Screws with Cruciform Recess400.734– 1.5 mm Titanium Cortex Screws, self-tapping,400.748 with cruciform recess, 4 mm–12 mm, 14 mm,

16 mm, 18 mm


16 mm, 18 mm

2.0 mm Screws with Cruciform Recess401.154– 2.0 mm Titanium Cortex Screws, self-tapping,401.174 with cruciform recess, 4 mm –12 mm,

14 mm–24 mm (2 mm increments)


16 mm, 18 mm

Cruciform Screwdriver Blades, self-retainingHex coupling

313.917 1.3 mm

313.935 1.5 mm/2.0 mm, short

313.936 1.5 mm/2.0 mm, long

313.943 1.5 mm/2.0 mm, medium

Mini quick coupling

313.911 1.0 mm, wedge

313.916 1.3 mm, wedge

313.922 1.5 mm/2.0 mm, wedge, short

313.923 1.5 mm/2.0 mm, wedge, long

313.922

313.916

313.911


Cruciform and PlusDrive Screws

1.0 mm PlusDrive Screws400.402– 1.0 mm Titanium Cortex Screws, self-tapping,400.414 with PlusDrive recess, 2 mm–12 mm, 14 mm

400.422, 1.0 mm Titanium Cortex Screws, self-drilling, 400.423 with PlusDrive recess, 2 mm and 3 mm

400.462– 1.2 mm Titanium Emergency Screws, with 400.474 PlusDrive recess, 2 mm–12 mm, 14 mm

1.3 mm PlusDrive Screws400.433– 1.3 mm Titanium Cortex Screws, self-tapping,400.448 with PlusDrive recess, 3 mm–10 mm, 12 mm,

14 mm, 16 mm, 18 mm

400.453– 1.3 mm Titanium Cortex Screws, self-drilling, 400.456 with PlusDrive recess, 3 mm–6 mm

400.483– 1.7 mm Titanium Emergency Screws, with 400.498 PlusDrive recess, 3 mm–10 mm, 12 mm,

14 mm, 16 mm, 18 mm

PlusDrive Screwdriver Blades, self-retainingHex coupling314.485 1.0 mm, 75 mm

313.805 1.3 mm, 52 mm

313.806 1.3 mm, 76 mm

Cruciform Screwdriver Blades with Spring Holding SleeveCompatible with 1.0 mm PlusDrive screws314.481 1.0 mm

314.482 1.0 mm, hex coupling

Compatible with 1.3 mm PlusDrive screws314.413 1.3 mm

314.491 1.3 mm, hex coupling

314.485

313.805

Synthes 21

1.5 mm PlusDrive Screws400.034– 1.5 mm Titanium Cortex Screws, self-tapping,400.048 with PlusDrive recess, 4 mm–8 mm, 10 mm,

12 mm, 14 mm, 16 mm, 18 mm


400.274– 2.0 mm Titanium Emergency Screws, with 400.288 PlusDrive recess, 4 mm–8 mm, 10 mm,

12 mm, 14 mm, 16 mm, 18 mm

2.0 mm PlusDrive Screws401.041– 2.0 mm Titanium Cortex Screws, self-tapping,401.044 with PlusDrive recess, 4 mm–8 mm

401.045– 2.0 mm Titanium Cortex Screws, coarse pitch,401.052 self-tapping, with PlusDrive recess,

10 mm–24 mm (2 mm increments)


401.791– 2.4 mm Titanium Emergency Screws, with 401.799 PlusDrive recess, 5 mm, 6 mm–18 mm

(2 mm increments)

PlusDrive Screwdriver Blades, self-retainingHex coupling313.252 1.5 mm/2.0 mm, 96 mm

313.253 1.5 mm/2.0 mm, 76 mm

313.254 1.5 mm/2.0 mm, 52 mm

Cruciform Screwdriver Blades with Spring Holding SleeveCompatible with 1.5 mm PlusDrive screws314.651 1.5 mm, short, hex coupling

314.667 1.5 mm, short

314.668 1.5 mm, long

314.682 1.5 mm, long, hex coupling

Compatible with 2.0 mm PlusDrive screws314.672 2.0 mm, short

314.673 2.0 mm, long

314.675 2.0 mm, short, hex coupling

314.684 2.0 mm, long, hex coupling

313.252

313.253

313.254

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

Synthes (Canada) Ltd.2566 Meadowpine BoulevardMississauga, Ontario L5N 6P9Telephone: (905) 567-0440To order: (800) 668-1119Fax: (905) 567-3185

© 2007 Synthes, Inc. or its affiliates. All rights reserved. PlusDrive and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 7/10 J6168-B

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