PSI Patient Specific Implants. Derived from CT data for excellent reconstructive results.

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1 PSI Patient Specific Implants. Derived from CT data for excellent reconstructive results. Better anatomic fit Reduced operating time Satisfying aesthetic results

2 PSI Patient Specific Implants Intended for the replacement of bony voids in the cranial/ craniofacial skeleton. Features Better anatomic fit versus conventional fixation/ reconstruction methods Reduced operating time compared to traditional reconstruction methods that require extensive contouring Satisfying aesthetic results for surgeon and patient Suitable materials for definitive treatment Impact- and fracture-resistant for optimal protection of underlying structures Autoclavable withstands repeated sterilization Synthes Patient Specific Implants are derived from 1 mm slice DICOM uncompressed CT data, which is obtained from the hospital radiology department. Synthes CMF PSI Patient Specific Implants

3 Medical imaging software is used to visualize the CT data, and to create an anatomically correct skull model and an implant model. Surgeons have a choice of two biocompatible materials: PEEK (polyetheretherketone) or Commercially pure (CP) titanium Synthes CMF

4 PSI Patient Specific Implants continued Synthes will fabricate one nonsterile implant for shipment to the surgeon, after receipt of purchase order and design approval. Synthes plates and screws are used to attach the Patient Specific Implant to the native bone. Synthes CMF PSI Patient Specific Implants

5 Applications Synthes Patient Specific Implants can be designed to fit voids in the cranial and craniofacial skeleton. Cranial Applications Depending on the size (length, width, and height) of the implant required, Synthes may design a single or multi-piece implant. Multi-piece implants allow the surgeon greater flexibility when treating larger defects. 1-piece 2-piece 2-piece Multi-piece implants may be joined together using Synthes standard cranial and craniofacial fixation systems. 2-piece 3-piece 1-piece Craniofacial Applications Onlay Applications 1-piece 3-piece 2-piece onlay 2-piece onlay 3-piece 1-piece 1-piece onlay 1-piece onlay Synthes CMF

6 Choice of Material PEEK (Polyetheretherketone) Engineered for strength, stability and biocompatibility Radiolucent (minimal MRI artifact) Bone-like strength Surgeon can determine plate and screw placement during surgery Lightweight Autoclavable withstands repeated sterilization Can be used with Synthes cranial and craniofacial fixation systems Implant is 3.0 mm thick (nominal) If modifications of a PEEK implant are required (e.g. drainage, monitoring devices), they can be performed in the OR with standard instruments PEEK Mechanical Properties Cortical Bone PEEK Modulus of Elasticity (stiffness) (GPa) Yield Strength (MPa) Notes regarding the use of PEEK Patient Specific Implants: PEEK patient specific implants require minimal (if any) modification. For minor fit modifications, it is suggested that the surgeon modify the patient bone rather than modifying the PEEK patient specific implant. PEEK patient specific implants can be modified with a high speed burr, if needed. It is suggested that the PEEK implants be modified and rinsed in sterile saline solution away from the implant/surgical site, to ensure that particulate debris does not infiltrate the surgical site after any modifications. Standard plates and self-tapping or self-drilling screws can be used to attach the PEEK patient specific implant to the patient. Screw holes, regardless of screw size and type, must be predrilled away from the surgical site. Synthes CMF PSI Patient Specific Implants

7 Titanium (commercially pure, implant grade) Ultra-high strength Radiopaque Excellent biocompatibility Autoclavable withstands repeated sterilization Requires the use of Synthes Low Profile Neuro or MatrixNEURO plate and screw fixation systems Requires the use of Titanium Low Profile Neuro Machine Screws ( ) for attachment of the plates to the implant (see Figure 1) Titanium implant is 2.5 mm thick (nominal) 1.6 mm Titanium Machine Screw ( ) Bone Screw Plate Titanium PSI Implant Bone Figure 1 Titanium Mechanical Properties Cortical Bone Titanium Modulus of Elasticity (stiffness) (GPa) Yield Strength (MPa) (minimum) Notes regarding the use of Titanium Patient Specific Implants: Titanium patient specific implants cannot be modified. If there are any minor fit modifications required, the surgeon must modify the patient s bone. Titanium patient specific implants require the use of Synthes Low Profile Neuro or MatrixNEURO fixation systems (plates and screws). The surgeon must preselect the location of Synthes plates and machine screw holes during the implant design review process. The implant will be provided with threaded screw holes. The Titanium Low Profile Neuro Machine Screws ( ) are required for attachment of the Low Profile Neuro or MatrixNEURO plates to the titanium implant. Synthes CMF

8 2007 Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 1/10 J7844-E 2007 Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 1/10 J7770-E Ordering Process 1 Surgeon sends patient to radiology to be scanned according to Synthes CT Scanning Protocol. CT Scanning Protocol Synthes Patient Specific Implants This document describes the guidelines for a CT scan that is taken for the purpose of ordering a Patient Specific Implant from Synthes. Notice: Patient Specific Implants are intended for the replacement of bony voids in the cranial/craniofacial skeleton. Synthes CT Scanning Protocol can be obtained from a Synthes Sales Consultant or at Scanning Instructions Ensure scanner is DICOM compliant. Refer to supported scanner list below. Scans must be less than four months old. Data must be on CD or Magnetic Optical Disk (MOD) only. Films will not be accepted. Scan all slices of the study in the same direction. Align the patient in a way that prevents as many artifacts as possible in the resulting images. It is advised not to use a gantry tilt because data may be of inferior quality. Scan with the same slice spacing; the slice spacing must be less than or equal to the slice thickness. The slice thickness should be between mm and 1.25 mm. Reconstruct the images with a 512 x 512 matrix. Only the axial images are required. All slices must have the same field of view, the same reconstruction center, and the same table height. Send the images (DICOM slices) to the surgeon. DICOM Compliant Scanners Siemens Somatom Plus Siemens Somatom HiQ Siemens Somatom DRH Siemens Somatom AR Siemens Somation 4 Plus, Volume Zoom Siemens Somatom 4AR Siemens Magnetom (MR Scanner) Siemens Somatom Balance Siemens Somatom AR Star Siemens Magnetom (MR) Siemens Magnetom Expert Siemens Emotion Duo Siemens GBS III Toshiba MEC Asteion Toshiba MEC Aquilion Toshiba Aquilion Toshiba Toshiba Xvision/EX Toshiba XPress/SX, GX, HS1 Philips Easyvision Philips Tomoscan 60/TX, TX Philips Tomoscan CX, CX/S, CX/Q Philips Tomoscan LX, LX/C, SR Philips Medical Systems AVE1 Philips Medical Systems 6000 Hitachi W950, W2000, MRP 7000 Hitachi 7000, AVEU, LX, T Hitachi CT95, CT20 GE Hilight Advantage GE Advantage GE Hispeed GE Sigma (MR) GE LightSpeed QX/i GE HiSpeed RP, CT/I, Advantage GEMS Jupiter, Zeus, ZeusRP GEMS Genesus_Zeus, Genesus_Signa GE Prospeed, Cytec, CT Pace GE Prospeed Plus GE Cytec 3000i GE9800 GE CT/I Yokogawa Medical Systems Format Elscint Exel 2400 Elscint CT Twin Elscint Elite Elscint OmniPro Elscint Twin Flash Picker PQ 2000, PQ 5000, 6000 Picker UltraZ Picker MxTwin Picker MX8000 Picker Sys9049 Picker International Polaris 1.0T Picker International PQS Use the following scan parameters or the closest approximation possible: Matrix 512 x 512 Slice Thickness 1.0 mm Feed per Rotation 1.0 mm Reconstructed Slice Increment 1.0 mm Reconstructed Algorithm Bone or High Resolution Gantry Tilt 0º Accepted Media CD or MOD Synthes only accepts uncompressed DICOM data. Note on Disc: Scanner type, date of scan, patient name and number, surgeon, hospital, contact number. Contact: Patient Specific Implants Help Desk at (610) , or by at 2 The completed Request for Quote (RFQ) form and the CT scan (according to the CT Scanning Protocol) are both sent together to: Synthes CMF Attn: Patient Specific Implant Department 1301 Goshen Parkway West Chester, PA Request for Quote Synthes Patient Specific Implants Notice: Patient Specific Implants are intended for the replacement of bony voids in the cranial/craniofacial skeleton. Please send: Mail to: Surgeon and Shipping Information: 1. Completed Request for Quote form Synthes CMF Patient Specific Implants and skull 2. CT Scan/Optical Disc from radiology Attn: Patient Specific Implant Department models must be shipped directly to (with scanner type, date of scan, 1301 Goshen Parkway surgeon; no P.O. boxes. Please indicate patient name/number on disc) West Chester, PA exact name and location for model and implant to be shipped. Shipping Information This Patient Specific Implant will be supplied with the understanding that the surgeon will make the sole determination for its use and application. Surgeon name* Hospital contact/title to receive implant* Mailing address* City State Zip code Office number* Office fax* address* Secondary contact name Secondary number Secondary CT scan and RFQ can be sent overnight via Synthes PSI prepaid mailers. Billing Information Hospital name* Purchasing contact Purchasing office number Synthes account #* Implant Information Account on credit hold?* Synthes suggests that surgery not be scheduled until Synthes receives the PO and the surgeon completes design validation. Patient name* Planned surgery date Patient ID number* Scan date* Notes Scans must be less than four months old. Films will not be accepted. Patient s CT scan and any additional patient information will be used solely for the production of a Patient Specific Implant. All patient information will be kept confidential. The data can be sent either by mail (express) or fax. Implant material (choose one):* PEEK Titanium Design validation method (choose one):* Skull model CAD images via Description of defect* Approximate defect location and shape (please draw/annotate defect) *Denotes required fields Contact: Patient Specific Implants Help Desk at (610) , or by at Synthes CMF PSI Patient Specific Implants

9 3 Synthes designs the implant and provides a quote to the customer. The computer images and/or skull model will be sent to the surgeon for review and approval. Note: If the CT data cannot be reconstructed into a 3-D format, Synthes will request a modified scan. If the defect is not clearly defined, Synthes will contact the surgeon to verify the margins of the defect. In both instances, additional time will be needed. Most defects have borders which are clearly defined on the CT scan, and a quotation can be prepared upon receipt of the scan and the RFQ form. Partially resorbed bone within the defect area (highlighted red), removal of existing implants, unclear defects and resections are some situations which will require consultation with the surgeon to define the implant configuration before the quotation process can begin. Synthes CMF

10 Ordering Process continued 4 Review and approval of the design can be done in one of two ways: 1. A skull model and an implant model are shipped to the surgeon, or 2. Computer images of the defect, the implant and the implant fitted into the defect are sent electronically to the surgeon Surgeon approves the design. Prompt approval of the design is required for the implant to be manufactured in a timely fashion. If changes are required at this stage, the model will be modified, reviewed and ap proved by the surgeon again. This will delay the start of implant manufacture. 6 When the purchase order and design approval are received, Synthes starts manu facturing the implant. After manufacturing, one nonsterile implant will be shipped overnight to the surgeon. Synthes CMF PSI Patient Specific Implants

11 Ordering Process Overview Start Receipt of RFQ, CT Scan* by PSI Department 3 Business Days Verification of the request Yes Initial design of the implant No Feedback to the customer Quote and implant design to the customer Design approved No + 2 days Re-design of the implant Depends on customer follow-up Yes Receipt of purchase order No No order will be placed Yes 4 Business Days Finalize the design for manufacturing** Manufacturing Overnight shipment to customer *Following Synthes CT Scanning Protocol **Additional manufacturing time is necessary for PEEK PSI involving the midface or orbit, and for all Titanium PSI. Delivery timelines for these PSIs will be communicated at time of quote. Synthes CMF

12 Synthes CMF 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610) Synthes (Canada) Ltd Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) To order: (800) Fax: (905) Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 8/11 J5245-G

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