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Mandibular Body Posterior Cranial Vault Mandibular Body Transport Mandibular Ramus Craniomaxillofacial (CMF) Distraction System Unique Patients, Flexible Solutions

Craniomaxillofacial (CMF) Distraction System...Maxillofacial Reconstruction. Plast Reconstr Surg. 2013; 132(3): 626–633. 4. Xia JJ, Shevchenko L, Gateno J, Teichgraeber JF, Taylor

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Page 1: Craniomaxillofacial (CMF) Distraction System...Maxillofacial Reconstruction. Plast Reconstr Surg. 2013; 132(3): 626–633. 4. Xia JJ, Shevchenko L, Gateno J, Teichgraeber JF, Taylor

Mandibular Body

Posterior Cranial Vault Mandibular Body Transport

Mandibular Ramus

Craniomaxillofacial (CMF) Distraction SystemUnique Patients, Flexible Solutions

Page 2: Craniomaxillofacial (CMF) Distraction System...Maxillofacial Reconstruction. Plast Reconstr Surg. 2013; 132(3): 626–633. 4. Xia JJ, Shevchenko L, Gateno J, Teichgraeber JF, Taylor

Patient Activation Instrument

• Patient Activation Instrument designed to prevent unintended device reversal

Craniomaxillofacial (CMF) Distraction SystemA modular system for cranial and mandibular distraction provides intraoperative flexibility to accommodate surgeon and patient needs.

Flexible Solutions to Meet the Needs of Each PatientOne system. Four Indications. 1000+ configurations.

View Distractor Assembly Guide

Distractor bodiesAnti-reversal mechanism

• Anti-reversal detent clip locate discretely within distractor body for consistent, smooth profile and reduced impact to soft tissue

No need for locking

• Anti-reversal mechanism does not require intraoperative locking to prevent backward rotation of the distractor

• It can be readily activated in the correct direction by use of the Patient Activation Instrument

Extension armsDesigned to Limit Soft Tissue Interference

• Extension arms provide access to point of distractor activation from various distances

• Rigid and flexible extension arms can be removed after the activation period

• Flexible extension arms with in line removal to easily disengage in presence of soft tissue coverage

Footplates

• Footplates, screws and screwdriver blades are color coded to simplify the surgical workflow and may improve efficiency and decrease OR time

Raised Head Screws

• Raised Head Screws and Screwdriver Blades are designed to aid in screw removal from difficult to reach anatomical regions.

• Raised Head Screws and PLUSDRIVE® Screws can be used interchangeably

Page 3: Craniomaxillofacial (CMF) Distraction System...Maxillofacial Reconstruction. Plast Reconstr Surg. 2013; 132(3): 626–633. 4. Xia JJ, Shevchenko L, Gateno J, Teichgraeber JF, Taylor

Our total solution seamlessly integrates virtual surgical planning and intraoperative patient-specific tools to help achieve your goals of:

• Accuracy through visualization of anatomy and identification of surgical challenges within a 3D planning environment, intraoperative patient-specific tools to accurately transfer the plan to the OR, and personalized implants.2,5,7

• Efficiency through virtual surgical planning assisted by experienced clinical engineers to optimize preparation, surgical time and the number of procedural steps.1,3,5,10

• Patient Benefit by striving to achieve satisfying aesthetic results and minimizing operative time.4,6,8,9,11

Services and products available for distraction*:

Live interactive planning session with a knowledgeable team of clinical engineers

Surgical Guides function as cutting and drilling guides to transfer the plan to the operating room

Anatomic Models for bending distractor footplates preoperatively

References:1. Xia JJ, Phillips CV, Gateno J, Teichgraeber JF, Christensen AM, Gliddon MJ, Lemoine JJ, Liebschner MAK. Cost-

Effectiveness Analysis for Computer-Aided Surgical Simulation in Complex Cranio-Maxillofacial Surgery. J Oral Maxillofac Surg. 2006(64): 1780–1784.

2. Hsu SS-P, Gateno J, Bell RB, Hirsch DL, Markiewicz MR, Teichfraeber JF, Zhou X, Xia JJ. Accuracy of a Computer-Aided Surgical Simulation Protocol for Orthognathic Surgery: A Prospective Multicenter Study. J Oral Maxillofac Surg. 2013; 71(1): 128–142.

3. Saad A, Winters R, Wise MW, Dupin CL, Hilaire HS. Virtual Surgical Planning in Complex Composite Maxillofacial Reconstruction. Plast Reconstr Surg. 2013; 132(3): 626–633.

4. Xia JJ, Shevchenko L, Gateno J, Teichgraeber JF, Taylor TD, Lasky RE, English JD, Kau CH, McGrory KR. Outcome Study of Computer-Aided Surgical Simulation in the Treatment of Patients with Craniomaxillofacial Deformities. J Oral Maxillofac Surg. 2011(69): 2014–2024.

5. Rodby KA, Turin S, Jacobs RJ, Cruz JF, Hassid VJ, Kolokythas A, Antony AK. Advances in oncologic head and neck reconstruction: Systematic review and future considerations of virtual surgical planning and computer aided design/computer aided modeling. J Plast Reconstr Aesthet Surg. 2014 Sep; 67(9): 1171–1185.

6. Modabber A, Gerressen M, Stiller MB, Noroozi N, Fuglein A, Holzle F, Riediger D, Ghassemi A. Computer assisted mandibular reconstruction with vascularized iliac crest bone graft. Aesth Plast Surg 2012 Jun;36(3):653-659.

7. Roser SM, Ramachandra S, Blair H, Grist W, Carlson GW, Christensen AM, Weimer KA, Steed MB. The accuracy of virtual surgical planning in free fibula mandibular reconstruction: comparison of planned and final results. J Oral Maxillofac Surg. 2010 Nov; 68(11):2824-32.

8. Leiggener C, Messo E, Thor A, Zeilhofer H.-F, Hirsch J.-M: A selective laser sintering guide for transferring a virtual plan to real time surgery in composite mandibular reconstruction with free fibula osseous flaps. Int. J. Oral Maxillofac. Surg. 2009; 38: 187–192.

9. Zanotti B, Zingaretti N, Verlicchi A, Robiony M, Alfieri A, Parodi PC. Cranioplasty: Review of Materials. J Craniofac Surg. 2016;27(8):2061-2072

10. Ayoub N, Ghassemi A, Rana M, et al. Evaluation of computer-assisted mandibular reconstruction with vascularized iliac crest bone graft compared to conventional surgery: a randomized prospective clinical trial. Trials. 2014;15:114.

11. Zhang WB, Yu Y, Wang Y, et al. Improving the accuracy of mandibular reconstruction with vascularized iliac crest flap: Role of computer-assisted techniques. J Craniomaxillofac Surg. 2016;44(11):1819-1827.

Products and services for distraction*,**:

SD900.006 Patient Specific Instrument and Planning Kit, Distraction

SD900.090 Planning Session only

SD900.092 Outcome Analysis Service

SD900.107 Patient Specific Guide, Distractor Positioning

SD900.201 Anatomical Model, Mandible, Clear

SD900.238 Planned Model, Maxilla - Cranium, Clear

SD900.266 Anatomical Model, Child, Mandible - Orbit, Clear

TRUMATCH® CMF Personalized Solutions offered for preoperative planning

* powered by Materialise** these articles cannot be ordered directly

Page 4: Craniomaxillofacial (CMF) Distraction System...Maxillofacial Reconstruction. Plast Reconstr Surg. 2013; 132(3): 626–633. 4. Xia JJ, Shevchenko L, Gateno J, Teichgraeber JF, Taylor

Craniomaxillofacial (CMF) Distraction System(not shown in actual size)

Distractor BodiesAB Distractor Bodies, End-activated (Center-translating)04.315.003 15 mm 04.315.004 20 mm04.315.005 25 mm04.315.006 30 mm04.315.053 with Universal Joint, 15 mm04.315.054 with Universal Joint, 20 mm04.315.055 with Universal Joint, 25 mm04.315.056 with Universal Joint, 30 mm

BC Distractor Bodies, End-activated (End-translating)04.315.023 15 mm 04.315.024 20 mm04.315.025 25 mm04.315.026 30 mm04.315.027 35 mm04.315.028 40 mm04.315.063 with Universal Joint, 15 mm04.315.064 with Universal Joint, 20 mm04.315.065 with Universal Joint, 25 mm04.315.066 with Universal Joint, 30 mm04.315.067 with Universal Joint, 35 mm04.315.068 with Universal Joint, 40 mm

Removable Extension Arms04.315.104 rigid, 20 mm04.315.108 rigid, 40 mm04.315.112 rigid, 60 mm04.315.125 flexible, 30 mm04.315.127 flexible, 40 mm04.315.132 flexible, 60 mm

Footplates1.0 mm Footplates04.315.201 Mesh foot, A-Type 04.315.202 Mesh foot, B-Type 04.315.203 Mesh foot, C-Type

1.3 mm Footplates04.315.501 Mesh foot, A-Type 04.315.502 Mesh foot, B-Type 04.315.503 Mesh foot, C-Type04.315.511 Cloverleaf foot, A-Type 04.315.512 Cloverleaf foot, B-Type 04.315.513 Cloverleaf foot, C-Type

1.5 mm Footplates04.315.301 Mesh foot, A-Type 04.315.302 Mesh foot, B-Type 04.315.303 Mesh foot, C-Type04.315.311 Cloverleaf foot, A-Type 04.315.312 Cloverleaf foot, B-Type 04.315.313 Cloverleaf foot, C-Type04.315.321 Elevated Mesh, B-Type 5.5 mm04.315.322 Elevated Mesh, B-Type 7.5 mm04.315.323 Elevated Mesh, C-Type

2.0 mm Footplates04.315.401 Mesh foot, A-Type 04.315.402 Mesh foot, B-Type 04.315.403 Mesh foot, C-Type04.315.411 Cloverleaf foot, A-Type 04.315.412 Cloverleaf foot, B-Type 04.315.413 Cloverleaf foot, C-Type04.315.421 Elevated Mesh, B-Type 5.5 mm04.315.422 Elevated Mesh, B-Type 7.5 mm04.315.423 Elevated Mesh, C-Type

Raised Head Screws PLUSDRIVE®

Emergency screw Raised Head Screws PLUSDRIVE®

Screw Ø Screw Type Length (mm) Drill Bit Ø Screw Ø Screw Type Length (mm)

1.0 mm Self-tapping 4, 6, 8 0.76 mm 1.2mm Self-tapping 4, 6, 8

1.3 mm Self-drilling

Self-tapping

4, 6,

8, 10, 12 1.0 mm 1.7mm Self-tapping 4, 6, 8, 10, 12

1.5 mm Self-drilling

Self-tapping

4, 6, 8,

10, 12 1.1 mm 2.0mm Self-tapping 4, 6, 8, 10, 12

2.0 mm Self-drilling

Self-tapping

4, 6, 8,

10, 12 1.5 mm 2.4mm Self-tapping 5, 6, 8, 10, 12 Self-drilling Self-tapping Emergency

Please also refer to the package insert(s) or other labeling associated with the devices identied in this brochure for additional information.

CAUTION: Federal Law restricts these devices to sale by or on the order of a physician.

Some devices listed in this sell sheet may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada.

Not all products may currently be available in all markets.

All third party trademarks are the trademarks of their respective owners.© DePuy Synthes 2020. All rights reserved. 133424-200226 DSUS 05/20

Manufactured or distributed by:Synthes USA, LLC 1101 Synthes Avenue Monument, CO 80132

To order (USA): 800-523-0322

www.jnjmedicaldevices.com

Note: For recognized manufacturer, refer to the product label.*