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Patient Specific Implants are intended for the replacement of bony voids in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone).

The Patient Specific Implants (PSI) are preformed implantable devices used to reconstruct portions of a patient's skull. The implant is designed using CT data to produce a preformed/pre-shaped implant that will fit the anatomy of a specific patient and is manufactured from PEEK (polyetheretherketone). The PSIs are provided non-sterile and are surgically attached to the native bone using commercially available Synthes 1.3 mm – 2.0 mm screws.

The manufacturing process is subtractive manufacturing (CNC milled) from models created and developed from patient specific CT Scan Data. The software used in this process is similar to the software used in the predicate device (K220357). This submission covers the use of software as an enabling technology that can be used as an option for the design of Patient Specific Implants. The device is designed to meet the needs of a specific patient upon request from a physician, and the basic design specifications must fall within the parameters defined in previous clearance for the system under K033868 / K053199. All designs must be approved by the physician prior to manufacture.

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