This publication is not intended for distribution in the USA.

Overview Brochure

AccuracyEfficiency Patient Benefit

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OVERVIEW

TRUMATCH® CMF SOLUTIONSDeliver advanced technology and procedural support for facial reconstruction, orthognathic surgery, distraction and cranial reconstruction.

SURGICAL GUIDES

ORTHOGNATHIC SPLINTS

ANATOMIC MODELS

TRUMATCH® CMF SOLUTIONS

PERSONALIZED PLATES AND IMPLANTS

VIRTUAL SURGICAL PLANNING

CRANIAL RECON

DISTRACTION OSTEOGENESIS

ORTHOGNATHIC SURGERY

MANDIBLE AND MIDFACE RECON

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

1. 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.

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. Leiggener C, Messo E, Thor A, Zeilhofer HF, 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.

4. 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.

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. 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.

7. 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.

8. 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.

9. 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.

10. Zanotti B, Zingaretti N, Verlicchi A, Robiony M, Alfieri A, Parodi PC. Cranioplasty: Review of Materials. J Craniofac Surg. 2016;27(8):2061-207211. 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.

Accuracythrough 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

Efficiencythrough virtual surgical planning assisted by experienced clinical engineers to optimize preparation, surgical time and the number of procedural steps

Patient Benefitby striving to achieve satisfying aesthetic results and minimizing operative time 1–11

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TITANIUM 3D MILLED PLATE FOR MANDIBLE

The design of the TRUMATCH® CMF Titanium 3D Milled Plates for Mandible is individually engineered to meet the needs of each patient and surgeon. By selecting plate design features, surgeons can customize the reconstruction plate to create a patient-specific solution. The Plates are 3D-milled to the planned patient anatomy, eliminating the step for intraoperative adaption and creating a stronger plate* with a lower overall profile.

The plates are never bent, consequently there is no induced stress due to bending.

INTENDED USE

Patient-Specific Plates for Mandible are intended for oral, maxillofacial surgery.

INDICATIONS

Trauma and Reconstructive surgery.

3D-milled for the patient

PERSONALIZED PLATES AND IMPLANTS Features and Benefits

Derived from Patient CT Data

• Design fits the planned outcome for easy positioning of the grafts at the planned location

• Integration with virtual surgical plan ning service** for seamless transfer of the surgical plan into the OR, using patient-specific surgical guides** with built-in drill guides that align with the plate holes (optional)

Customizable Design Features

• Screw hole positions and angulations defined indivi du ally to avoid screw interference with nerves, tooth roots, osteotomies, existing or future implants

• Screw length prediction and pre- visualization of screw trajectories to ensure a collision free construct

• Compatible with MatrixMANDIBLE Condylar Head Add-on

Strength with Low Profile

• 2.0 mm and 2.5 mm plate thicknesses for improved fatigue strength* with lower profiles compared to standard reconstruction plates

* Fatigue testing data shows increased fatigue life of both 2.0 and 2.5 mm profiles in comparison with MatrixMANDIBLE 2.5 mm thick plates. Test data does not indicate clinical performance. Test data on f le at DePuy Synthes - MT12-261: Dynamic Testing of Patient-Specific Mandible Plates (PSMP), 0000073412

** Manufactured by Materialise and distributed by DePuy Synthes

Surgical Guide

Max. 15°

8.0 mm

2.5 mm2.0 mm

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Features and Benefits

• Better anatomic fit versus conventional fixation/ reconstruction methods 1,2*

• Reduced operating time compared to traditional reconstruction methods that require extensive contouring 1,2*

• Satisfying aesthetic results for surgeon and patient 1,2*

• Suitable materials for definitive treatment

• Any necessary modifications of a PEEK implant (e.g. drainage, monitoring devices) can be performed in the OR with standard instruments

• Implant fixation with DePuy Synthes plates and screw systems

• Short turnaround time

PEEK (Polyetheretherketone)

• Engineered for strength, and stability

• Radiolucent (minimal MRI artifact)

• Bone-like stiffness and strength

• Surgeon can determine plate and screw placement during surgery

• Lightweight

• Autoclavable

Other Services Offered

• One-to-one online design sessions for preoperative surgical planning

• Online surgeon accounts

• 3D tools for implant reviews

• Supply of 3D data (format STL)

1 Jalbert F, Boetto S, Nadon F, Lauwers F, Schmidt E, Lopez R. One-step primary reconstruction for complex craniofacial resection with PEEK custom-made implants. J. Cranio-Maxillofacial Surg. 2014;42:141–148.

2 Zanotti B, Zingaretti N, Verlicchi A, Robiony M, Alfieri A, Parodi PC. Cranioplasty: Review of Materials. J Craniofac Surg. 2016;27(8):2061-2072.* Results from case studies are not predictive of results in other cases. Results in other cases may vary.

• Better anatomic fit versus conventional fixation/reconstruction methods 1,2,*

• Implant fixation with DePuy Synthes plates and screw systems

• Suitable material for definitive treatment

INDICATIONS

Intended for replacement of bony voids in the cranial/craniofacial skeleton.

PERSONALIZED PLATES AND IMPLANTS

PEEK MILLED IMPLANTSDerived from CT data for satisfying reconstructive results 1,2,*

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Features and Benefits

Patient-Specific Plate Design

The location of screws and drilling vectors are defined in the planned position. Surgical access, bone volume and the avoidance of anatomical obstacles such as nerves and tooth roots are considered.

Retro Planning

Predetermined screw locations in the planned position are transposed back to the initial position.

Osteotomy and Drill Guide Design

Planned osteotomies, drill pilot hole locations and drilling vectors are integrated into the guide design, accurately transferring the surgical plan to the operating room.

Plate-Guide Color Coding

The guide and matching plate are color coded to help with identifying the right combination when multiple devices are used for the same surgery.

Designed for Matrix Compatibility

The plates and guides are designed and validated for compatibility with the MatrixMANDIBLE™, Matrix MIDFACE™, MatrixORTHOGNATHIC™ and MatrixNEURO™ screws and drill bits, depending on the application.

TRUMATCH CMF Titanium 3D Printed Plates and Guides is a direct and fully guided system for bone part repositioning. The system consists of patient-specific osteotomy and drill guides and patient-specific plates for the accurate transfer of the surgical plan to the operating room.

PERSONALIZED PLATES AND IMPLANTS

TITANIUM 3D PRINTED PLATES*Guided system for bone part repositioning

INDICATIONS

Intended for bone repositioning surgical operations for different indications:

• Orthognathic surgery• Trauma reconstruction (secondary osteotomy and repositioning of

the Zygoma) • Reconstruction surgery

CONTRAINDICATIONS

• Doubt on the reliability of patient’s anatomical scan, as the scan data may not guarantee that a patient’s anatomy is accurately represented,

• Mental or neurological health troubles making the patient unable to accept or to follow postoperative precautions,

• Smoking, • Bad quality or insufficient bone tissue, or blood circulation issues, • High sensibility to metallic materials, • In the presence of active or latent infections, • Pregnancy.

OrthognathicsZygoma Repositioning/ Orbital Floor Reconstruction

Midface Reconstruction

Mandible Reconstruction

TRUMATCH CMF Titanium 3D Printed Plates

TRUMATCH CMF Titanium 3D Printed Guides

* Manufactured by Materialise

Features• Porous structure

• Complex anatomical shape

• Predetermined screw locations

• No additional fixation plates needed

• Designed for energy absorption in case of impact (local plastic deformation of implant)**

Specific Design Features• Anatomical anchors & suture holes

• Drainage

• Variable thickness

• Combination of continuous andporous structures is possible

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PERSONALIZED PLATES AND IMPLANTS

TITANIUM 3D PRINTED IMPLANTS*Flexible design for every clinical situation

INDICATIONS

Intended for bone reconstruction and restoration of bone defects of: the cranium, frontal bone, orbital floor, wall and roof, maxilla, zygoma and mandibular bones. And more generally all defects caused by a trauma injury, tumor removal, and genetic diseases.

The implants can also be used for volumetric increase of facial skeletal (for example: chin, cheekbones, mandibular angles).

CONTRAINDICATIONS

• Doubt on the reliability of patient’s anatomical scan, as the scan data may not guarantee that a patient’s anatomy is accurately represented,

• Mental or neurological health troubles making the patient unable to accept or to follow postoperative precautions,

• Smoking, • Bad quality or insufficient bone tissue, or blood circulation issues, • High sensibility to metallic materials, • In the presence of active or latent infections, • Pregnancy.

Orbital Reconstruction

• Clinical applications include orbital floor, orbitalfloor and zygoma, supraorbital regions

• Compatible with the Matrix MIDFACE™ screwsand drill bits

Midface Reconstruction

• Clinical applications include zygoma, centralmidface, maxilla

• Dental implants support

• Compatible with the MatrixMIDFACE™ screwsand drill bits

Mandible Reconstruction

• Clinical applications include mandible volumetricreconstruction, graft containment

• Compatible with the MatrixMANDIBLE™ screwsand drill bits

Volumetric Increase of Facial Skeleton

• Clinical applications include chin, zygoma andmandibular angle

• Compatible with the MatrixMIDFACE™ andMatrixMANDIBLE™ screws and drill bits

Cranial Reconstruction

• Clinical applications include frontal, parietal,occipital regions

• Osteotomy guides available

• Compatible with the MatrixNEURO™ screws

* Manufactured by Materialise** Based on static tensile tests: HW-PorousiTi-14101G-verA Energy_Absorbation_Report

VIRTUAL SURGICAL PLANNING

CASE DATABASE

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PROPLAN CMF *Technology for precise and accurate surgical planning

• 2D and 3D preoperative visualization of thepatient anatomy and condition

• Virtual simulation and optimization of theskeletal osteotomies and reconstruction

• Improved communication between patientand surgery team

• Reduced surgical time¹–³**

• Making critical clinical decisions preoperatively

• Multiple cephalometric analysis options

• Soft-tissue simulation and photomapping (2Dand 3D)

• Live interactive virtual planning session with aknowledgeable clinical engineering team

• No software installation or softwareknowledge required

PROPLAN CMF

Used to perform the virtual surgical planning. It is operated mostly by the clinical engineers located at Materialise during the live interactive sessions.

PROPLAN CMF Online

Web-based module intended for: (1) Exchange information between DePuy Synthes sales representative, DePuy Synthes TRUMATCH CMF Team and Materialise.

(2) The surgeon use, allowing for case creation, data exchange, tracking and visualization of surgical plans, tools and implants.

Mandible and Midface Reconstruction

• Preoperative planning for virtual simulation ofresection, grafting and reconstruction

• Soft tissue simulation

Orthognathic Surgery

• Preoperative planning for virtual simulationof maxillary and mandibular osteotomies

• Cephalometric analysis

• Occlusion-based positioning

• Soft tissue simulation

• Photomapping

Distraction Osteogenesis

• Preoperative planning for virtual simulation ofosteotomies, positioning of DePuy Synthesdistractors and placement of footplates

Cranial Vault Reconstruction

• Preoperative planning for virtual simulation ofresection, grafting, reconstruction of bonysegments

• Soft tissue simulation

PROPLAN CMF is the virtual surgical planning platform consisting of two platforms:

* Manufactured by Materialise** Results from case studies are not predictive of results in other cases.

Results in other cases may vary.¹ Modabber A, Gerressen M, Stiller MB, Noroozi N, Füglein A, Hölzle F, Riediger D, Ghassemi A. Computer assisted mandibular reconstruction with vascularized iliac

crest bone graft. Aesth Plast Surg 2012 Jun;36(3):653-659.² 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):2824-32.³ Leiggener C et al. 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), doi:10.1016/j.ijom.2008.11.026.

INTRAOPERATIVE PATIENT-SPECIFIC

TOOLS

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PATIENT-SPECIFIC SURGICAL GUIDES*

Some examples include, but are not limited to:

• Mandible and midface resection and drilling guides

• Graft harvesting and drilling guides (e.g. fibula, iliac crest, scapula)

• Osteotomy and plate positioning guide for placement of distractor footplates

• Surgical guides for segment and/or graft resection and segment (re)placement in cranial vault reconstruction

• Osteotomy and drill guide for orthognathic surgery (3D printed Titanium)

• Osteotomy and drill guide for secondary osteotomy and repositioning of the Zygoma (3D printed Titanium)

Designed to assist with osteotomies and to accuratelytransfer the virtual surgical plan to the surgical site

Resection guide for midface reconstruction (polyamide)

Resection and drilling guide for mandible reconstruction (polyamide)

Osteotomy and drill guide for orthognathic surgery (3D printed Titanium)

Osteotomy and drill guide for secondary osteotomy and repositioning of the Zygoma (3D printed Titanium)

Graft harvesting and drilling guide (polyamide)

Osteotomy and foot plate positioning guide for distraction (polyamide)

Osteotomy guide for cranial vault reconstruction (polyamide)

Orientation indicator

Holes for temporary guide fixation

Irrigationports

Drill guides matching the plate’s holes position and angulation

Cutting slots designed per surgeon preference. Flange or slot design

* Manufactured by Materialise

INTRAOPERATIVE PATIENT-SPECIFIC

TOOLS

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PATIENT-SPECIFIC ORTHOGNATHIC SPLINTS* ANATOMIC MODELS*• TRUMATCH CMF orthognathic splints are patient-

specific surgical tools used to transfer the virtual plan to the OR, indicating the steps of the surgery based on the dentition (occlusal) information

• Intermediate and final occlusion splints available

• Multiple impression depth and buccal contour width available

• Various options to submit occlusion data: physical plaster models, optical scans of the plaster models or intraoral scan (no plaster model needed at all)

• Made of sterilizable clear acrylic

• Tactile representation of the anatomy or preoperative plan for surgical simulation and communication to the patient

• Facilitate communication with the surgical team and patient

• Highlighted critical anatomical structures like tooth roots and nerves

Three tooth impression depths Two widths of buccal contour Wiring holes Palatal strap for multi-piece maxilla * Manufactured by Materialise

WORKFLOW

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* The process for orthognathic surgery, distraction and cranial vault reconstruction follows a similar workflow. The process can be performed without personalized implants as well.

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VIRTUAL SURGICAL PLANNING, PLATES, GUIDES AND MODELS

• Start by logging into your PROPLAN CMF Online account or requestan account if you don’t have one (visit the Inter national section onwww.trumatchcmf.com to access the link and instructions)

• Alternatively, ask your sales consultant for support

• Create a new case, upload the patient CT Scan and fill in the preferencesfor the planning, guides, splints, models and implants

• Join the interactive virtual surgical planning session with an experiencedclinical engineer

• Validate your virtual surgical plan, then the patient-specific tools andfinally the personalized implants

• The guides, models and implants are manufactured and delivered to you

• You can now transfer the virtual plan to the patient, as you imagined it

• The same process applies for the milled and 3D printed plates

PEEK (MILLED) AND TITANIUM (3D PRINTED) IMPLANTS

• Start by filling a Request for Service and upload the CT scan

• We will design the implant according to your instructions and provide aquote; if required, an interactive design session can be done

• Approve the implant when you are satisfied and place an order; yoursales representative can help you with this

• We will manufacture the implant through milling or 3D printing,depending on the choice of implant

• The implant will be delivered to you

CT Scan patient/ Request for Service

CT Scan patient/ Request for Service

Approve plate* and guides

Manufacture

Interactive virtual planning

Design and Quote

Manufacture

Approve plan and plate* preference

Approve design and place order

Deliver plate, guides, models, splints

Delivery

Design plate* and guides

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5

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SERVICES AND PRODUCTS

AT A GLANCE

Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.jnjmedicaldevices.com

This publication is not intended for distribution in the USA.

All surgical techniques are available as PDF files at www.depuysynthes.com/ifu ©

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Personalized Implants

• Titanium 3D Milled Plates for Mandible

• PEEK Milled Implants

• Titanium 3D Printed Plates*

• Titanium 3D Printed Implants*

Patient-Specific Tools*

• Surgical guides

• Orthognathic splints

• Anatomic models

Virtual Surgical Planning*

• Planning kits

• Soft tissue simulation

• Photo mapping

• Outcome analysis

• STL file transfer

* Products and services manufactured by

and distributed by DePuy Synthes