Craniofacial Modular Fixation System (PDF)synthes.vo.llnwd.net/o16/Mobile/Synthes North... · 4...

Craniofacial Modular FixationSystem. For trauma of the midfaceand craniofacial area.

Wide selection of plate shapes and sizes

Three types of screw drive recesses,and four choices of diameter

Color-coded instruments andmodules for easy identification

Introduction

Product Information

Table of Contents

Craniofacial Modular Fixation Systems 2

Indications 2

AO Principles 3

Screws 4

Titanium Orbital Mesh Plates 5

Titanium Anatomic Orbital Floor Plates 6

1.3 mm and 1.5 mm Titanium Contourable Mesh Plates 8

1.0 mm Titanium Plates and Mesh Plates 10

1.3 mm Titanium Plates and Mesh Plates 11

1.5 mm Titanium Plates 12

2.0 mm Titanium Plates 13

Craniofacial Modular Fixation Systems 15

Synthes CMF

Features and Benefits– Wide offering of plate geometries, sizes, and strengths

– Plates are made from commercially pure (CP) titanium

– Screws are made from CP titanium or titanium alloy*

– Four screw diameters to choose from: 1.0 mm, 1.3 mm,1.5 mm and 2.0 mm

– Three available screw drive recesses: PlusDrive, StarDriveand Cruciform

– Emergency screws available for each screw diameter

– Color-coded modules and instrumentation(for additional information, please see Craniofacial Instrument and Module Information brochure)

IndicationsFor use in selective trauma of the midface and craniofacialskeleton, craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla and chin.

Craniofacial Modular Fixation Systems

1.0 mm and 1.3 mm plating systems

1.5 mm and 2.0 mm plating systems

2 Synthes CMF Craniofacial Modular Fixation System

* Ti-6Al-7Nb

Synthes CMF 3

AO Principles

In 1958, the AO ASIF (Association for the Study of InternalFixation) formulated four basic principles which have becomethe guidelines for internal fixation.1 Those principles, as applied to the Craniofacial Modular Fixation System, are:

Anatomic ReductionThe craniofacial plates are available in a wide variety of shapesand sizes. All plates can be contoured to allow reduction ofeven the most complex craniofacial fractures.

Stable FixationMultiple screw sizes and a range of plate strengths allow the surgeon to choose the construct that will provide appropriate stability 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 MobilizationPlate and screw features combined with AO technique create an environment for bone healing, expediting a return to optimal function.

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


Screws

PlusDrive– For use with 1.0 mm, 1.3 mm, 1.5 mm and 2.0 mm

plating systems

– Available in self-tapping and self-drilling (cortex) screws

– Used with 1.0 mm, 1.3 mm, and 1.5 mm/2.0 mm self-retaining PlusDrive screwdriver blades

– Cruciform screwdriver blades with spring holding sleevescan be used with PlusDrive screws to aid in difficult screwplacement

StarDrive– For use with 1.3 mm, 1.5 mm and 2.0 mm plating systems

– Available in both self-tapping (cortex) and self-drilling (cortex/cranial) screws

– Used with 1.3 mm, 1.5 mm and 2.0 mm self-retainingStarDrive screwdriver blades

– StarDrive screwdriver blades with spring holding sleeves can be used to aid in difficult screw placement

Cruciform– For use with 1.0 mm, 1.3 mm, 1.5 mm and 2.0 mm

plating systems

– Available in self-tapping (cortex) screws

– Used with 1.0 mm, 1.3 mm and 1.5 mm/2.0 mm self-retaining cruciform screwdriver blades

– Cruciform screwdriver blades with holding sleeves can be used to aid in difficult screw placement

Please see additional product information in back pocket for details.

Titanium Orbital Mesh Plates

Orbital Floor Mesh PlatesRecommended for all types of orbital fractures and reconstruction of the bony orbit.

Features– Radial design simplifies cutting

– Malleable material facilitates contouring

– Three rows of screw holes provide a variety of fixation points to adapt to orbital anatomy

– Available in 0.2 mm, 0.3 mm, and 0.4 mm thicknesses

– Available for use with 1.0 mm or 1.3 mm titanium screws

– Universal design for either right or left orbit

– Manufactured from commercially pure (CP) titanium

– Available sterile or nonsterile

Orbital Mesh Plates◊

1.0 mm 1.3 mm Thickness Color

420.302 421.302 0.2 mm Purple

420.303 421.303 0.3 mm Teal420.304 421.304 0.4 mm Gold

Enlarged view

Synthes CMF 5

Note: Plates shown actual size except where noted.◊ These implants are available nonsterile or sterile-packed.

Add “S” to product number for sterile product.


Titanium Anatomic Orbital Floor Plates

Features– Microperforation design minimizes tissue ingrowth

– Three configurations address large or small defects

– Anatomic design minimizes cutting

– Universal configuration can be used in left or right orbit

– Radial reliefs simplify contouring

– Malleable, 0.3 mm thick material facilitates anatomicadaptation

– Multiple screw holes provide a variety of fixation points


– Manufactured from commercially pure (CP) titanium

– Available sterile or nonsterile

Anatomic Orbital Floor Plate, small Recommended for small isolated orbital floor fractures.

Anatomic Orbital Floor Plate, medium Recommended for large orbital floor fractures.

Anatomic Orbital Floor Plate, large – Recommended for orbital floor defects with medial

and lateral wall involvement and reconstruction of tumor resections.

– Medial wing clears lacrimal duct

– M-shaped cutout designates medial wing

Anatomic Orbital Floor Plates◊

1.0 mm 1.3 mm

Small 420.401 421.048

Medium 420.403 421.043

Large 420.402 421.049

Universal Orbital Floor Plates and Medial Wall Plates◊

1.0 mm 1.3 mm 1.5 mm

Universal 420.40 421.040 446.40

Medial Wall L 420.44 421.044 446.44

Medial Wall R 420.45 421.045 446.45

Synthes CMF 7

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


1.3 mm and 1.5 mm Titanium Contourable Mesh Plates

Features– Plates are easily contoured without kinking

to match the irregular craniofacial anatomy

– Malleable and rigid mesh are available for most craniofacial repair and reconstruction indications


– Made from commercially pure titanium

– Available in a variety of shapes: rectangular, round and arc

Contourable Mesh PlatesMalleable, rectangular◊

421.004 1.3 mm, 38 mm x 45 mm

421.007 1.3 mm, 100 mm x 100 mm

446.014 1.5 mm, 38 mm x 45 mm

446.017 1.5 mm, 100 mm x 100 mm

Rigid, rectangular◊

421.005 1.3 mm, 38 mm x 45 mm

421.008 1.3 mm, 100 mm x 100 mm

421.009 1.3 mm, 200 mm x 200 mm

446.015 1.5 mm, 38 mm x 45 mm

446.018 1.5 mm, 100 mm x 100 mm

446.019 1.5 mm, 200 mm x 200 mm

Malleable MeshRigid Mesh


Contourable Mesh Plates continued

Malleable, arc◊

421.011 1.3 mm, small

421.012 1.3 mm, large

446.033 1.5 mm, small

446.034 1.5 mm, large

Rigid, arc◊

421.013 1.3 mm, small

421.014 1.3 mm, large

446.035 1.5 mm, small

446.036 1.5 mm, large

Malleable, round◊

421.015 1.3 mm, 30 mm diameter


421.017 1.3 mm, 100 mm diameter



446.052 1.5 mm, 100 mm diameter

Rigid, round◊



421.020 1.3 mm, 100 mm diameter



446.055 1.5 mm, 100 mm diameter

Synthes CMF 9

Malleable MeshRigid Mesh



1.0 mm Titanium Plates and Mesh Plates

X-Plate 5 holes420.81

T-Plate5 holes x 5 holes420.70

T-Plate 5 holes x 7 holes420.71

Y-Plate 2 holes x 5 holes420.62

Double Y-Plate 1 hole x 2 holes420.68

L-Plate 4 holes x 5 holes420.55 right420.54 left

H-Plate 6 holes420.84

Strut Plate16 holes, 30 mm420.01

Strut Plate 22 holes, 42 mm420.04

Adaption Plate , 34 holes, 100 mm420.10

Orbital Rim Plate11 holes420.21

Burr Hole Covers 420.900420.91

Mesh Plate Hole Spacing: 4.0 mm x 4.0 mm420.02 38 mm x 42 mm420.05 50 mm x 100 mm420.06 100 mm x 100 mm

Hole Spacing: 3.0 mm x 3.0 mm420.031 50 mm x 50 mm

Mesh Plate Hole spacing: 4.5 mm x 5.0 mm420.00 29 mm x 40 mm

Mesh Screen 100 mm x 100 mm420.070

Y-Plate3 holes x 7 holes420.63

H-Plate 11 holes420.85

Y-Plate4 holes x 10 holes420.631

1.3 mm Titanium Plates and Mesh Plates

Synthes CMF 11

Adaption Plate, 24 holes, 95 mm421.010

Orbital Rim Plate 9 holes, 35 mm421.021

Mesh PlateHole Spacing: 5.0 mm x 5.0 mm421.006 100 mm x 100 mm421.001 38 mm x 53 mm

Mesh Screen421.099 100 mm x 100 mm

Strut Plate, 18 holes 43 mm, 5 mm spacing421.080

X-Plate, 4 holes421.081

Box Plate, 4 holes13 mm x 8 mm421.095

H-Plate, 11 holes421.085

Burr Hole Cover, 6 holes421.090 12 mm dia.421.091 17 mm dia.421.092 15 mm dia.421.093 24 mm dia.

Oblique L-Plate 3 holes x 3 holes421.051 right421.050 left


Double Y-Plate22 mm, 6 holes421.067

Y-Plate 1 hole x 3 holes 421.061

Double Y-Plate 6 holes, 15 mm421.068


T-Plate3 holes base x 4 holes shaft421.071

Box Plate, 4 holes13 mm x 13 mm421.096


1.5 mm Titanium Plates

Adaption Plate, 20 holes, 90 mm446.10Adaption Plate, 20 holes, 90 mm, low profile446.101

Box Plate 4 holes446.096 14 mm x 14 mm446.097 16 mm x 16 mm446.916 16 mm x 10 mm


Oblique L-Plate, Malleable 3 holes x 4 holes446.537 right446.527 left

Y-Plate 1 hole x 3 holes 446.61

Y-Plate, malleable 1 hole x 3 holes450.611



X-Plate 4 holes446.81

Orbital Rim Plate 446.18 8 holes446.20 10 holes446.22 12 holes

Orbital Rim Plate, malleable446.538 8 holes446.540 10 holes446.542 12 holes

Adaption Plate, malleable, 20 holes, 90 mm450.101


Oblique L-Plate, malleable 2 holes x 3 holes446.515 right446.516 left

Burr Hole Cover, 6 holes446.900 12 mm dia.446.901 15 mm dia.446.91 17 mm dia.446.902 24 mm dia.

Synthes CMF 13

2.0 mm Titanium Plates

Zygomatic Plate (DCP) 5 holes, 27 mm443.45



Adaption Plate, 20 holes, 100 mm447.10

Oblique L-Plate 2 holes x 3 holes447.50 left447.51 right

Oblique L-Plate 3 holes x 4 holes447.52 left447.53 right

Orbital Rim Plate447.18 8 holes447.20 10 holes447.22 12 holes

Oblique L-Plate, malleable 2 holes x 3 holes447.515 right447.516 left

Adaption Plate with 30 Broad Spaced Holes, 193 mm447.38

T-Plate3 holes x 3 holes447.140 24 mm

T-Plate3 holes x 4 holes447.244 25 mm

Oblique L-Plate, malleable3 holes x 4 holes447.527 left447.537 right

Adaption Plate, malleable, 20 holes, 100 mm451.101


X-Plate, 4 holes447.81

Burr Hole Cover17 mm dia.447.91



Y-Plate 2 holes x 4 holes 447.62

Y-Plate, malleable2 holes x 3 holes447.630

Double Y-Plate2 holes each arm447.68

Double Y-Plate8 holes, 38 mm447.681

Y-Plate1 hole x 3 holes447.61


2.0 mm Titanium Plates continued

FeaturesTwo case options:– Two-module (one instrument level

and storage for two modules)(690.652)

– Four-module (one instrument leveland storage for four modules)(690.654)

Customizable instrument and implant options

Synthes CMF 15

Craniofacial Modular Fixation Systems (690.652 and 690.654)

Sterilization Parameters for Sets (690.652 and 690.654)These Synthes sets with all additionally available items, as marked in the cases,can be sterilized by the following parameters. For more information, please referto graphic case package insert.

Method Cycle Temperature Exposure Time

Steam Prevacuum 132°–135°C 8 Minutes(Wrapped) (270°–275°F)

Steam Gravity Displacement 132°–135°C 22 Minutes(Wrapped) (270°–275°F)

1.5 mm Module304.661


For additional information on the instruments, casesand trays for this system, please refer to the SynthesCraniofacial Instrument and Module Informationbrochure.



Notes


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. DCP, PlusDrive and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 2/07 J6169-A

www.synthes.com

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