TRUMATCH® CMF Patient Specific Implants

Division: CMF
Category: Cranial Solutions

TRUMATCH CMF Patient Specific Implants are derived from cT data for excellent reconstructive results.

PSI Applications

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.

PSI Materials

Surgeons have a choice of two biocompatible materials:

  • PEEK Optima-LT (polyetheretherketone) or
  • Commercially pure (CP) titanium

PEEK Optima-LT (Polyetheretherketone)

  • Engineered for strength, stability and biocompatibility
  • Radiolucent (minimal MRI artifact)
  • Bone-like stiffness and 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 3.0mm thick (nominal)
  • If modification of PEEK implants are required (e.g. drainage, monitoring devices), they can be performed in the OR with standard instruments
  • PEEK Mechanical Properties    
      Cortical Bone[1] PEEK[1]
    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)

  • Ultra-high strength as compared to cortical bone
  • Radiopaque
  • Excellent biocompatibility
  • Autoclavable - withstands repeated sterilization
  • Requires the use of Synthes Low Profile Neuro or MatrixNEURO plate and screw fixation system
  • Requires the use of Titanium Low Profile Neuro Machine Screws (488.066) for attachment of the plates to the implant
  • Titanium implant is 2.5mm thick (nominal)
  • Titanium Mechanical Properties
      Cortical Bone[1] Titanium[2]
    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.

[1] Mechanical test data on file at Synthes. Mechanical test results are not necessarily indicative of clinical performance.

[2] Per ISO 5832-2.

Indications for Use

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

Features & Benefits

  • Better anatomic fit versus conventional fixation/ reconstruction methods
  • Reduced operating time 
  • Satisfying aesthetic results for surgeon and patient
  • Manufactured from PEEK Optima-LTTM or commercially pure titanium for strength, stability and biocompatibility




PSI Ordering Process

Step 1
Surgeon sends patient to radiology to be scanned according to Synthes CT Scanning Protocol.

Step 2
Submit patient scan data (CT/CBCT scans, intraoral Scans, plaster models, etc.) with completed Request for Service (RFS) per the instructions on the RFS form


  • 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.

Step 3
DePuy Synthes Companies designs the implant and provides a quote to the customer.

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.

Step 4
Review and approval of the design can be done in one of two ways:

  1. A skull model and an implant prototype are shipped to the surgeon for design verification and approval.  Surgeon may approve electronically or by fax.
  2. Computer images of the defect and proposed implant showing fit are sent electronically to the surgeon for design verification and approval.  Surgeon may approve electronically or by fax.

Step 5
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/images will be modified, reviewed and approved by the surgeon again.  This will delay the start of implant manufacture.

Step 6
When the purchase order and design approval is received, DePuy Synthes Companies starts manufacturing the implant.  After manufacturing, one nonsterile implant will be shipped overnight to the surgeon.



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.