Category: Cranial Solutions
TRUMATCH CMF Patient Specific Implants are derived from cT data for excellent reconstructive results.
DePuy Synthes Patient Specific Implants can be designed to fit voids in the cranial and craniofacial skeleton.
Depending on the size (length, width and height) of the implant required, DePuy Synthes may design a single or multi-piece implant. Multi-piece implants allow the surgeon greater flexibility when treating larger defects.
Multi-piece implants may be joined together using DePuy Synthes standard cranial and craniofacial fixation systems.
Surgeons have a choice of two biocompatible materials:
PEEK Optima-LT (Polyetheretherketone)
|Modulus of Elasticity (stiffness) (GPa)||8-24||3.6-4.1|
|Yield Strength (MPa)||115||113|
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 the 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.
Titanium (commercially pure, implant grade)
|Modulus of Elasticity (stiffness) (GPa)||8-24||103|
|Yield Strength (MPa)||115||230|
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 the 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 (488.066) are required for attachment of the Low Profile Neuro or MatrixNEURO plates to the titanium implant.
 Mechanical test data on file at Synthes. Mechanical test results are not necessarily indicative of clinical performance.
 Per ISO 5832-2.
Intended for replacement of bony voids in the cranial/craniofacial skeleton.
PSI Ordering Process
The computer images and/or skull model will be sent out to the surgeon for review and approval.
Note: If the CT data cannot be reconstructed into a 3-D format, DePuy Synthes Companies will request a modified scan. If the defect is not clearly defined, DePuy Synthes Companies 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, 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.
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/images will be modified, reviewed and approved by the surgeon again. This will delay the start of implant manufacture.
All medical devices have associated risks. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings. For further information on DePuy Synthes Products, please contact your local DePuy Synthes Representative.