TECHFIT Patient-Specific Cranial System
Techfit Digital Surgery, Inc.The TECHFIT Patient-Specific Cranial System is a device designed to replace missing bone in the skull. It uses patient CT scans to create custom implants made from PEEK material, matched to the patient's anatomy. The system includes a software platform (DISRP®) for surgical planning and visualization, along with anatomical models to aid in preoperative preparation. This helps surgeons achieve accurate reconstruction tailored to each patient, improving surgical outcomes.
Intended Use
The TECHFIT Patient-Specific Cranial System is intended to replace bony voids in the cranial skeleton in adults and adolescents 18 years or older.
Technology
The system includes patient-specific cranial implants made from Polyether Ether Ketone (PEEK) manufactured via machining, anatomical models made by 3D printing for visualization, and a software component (DISRP®) for digital planning and surgical reconstruction visualization. The implants are fixed using commercially available cranial plates and screws.
Performance
Performance testing demonstrated high dimensional accuracy of implants, compatibility with JEIL Le Forte Neuro Plating System screws and plates, proper implant adjustment to patient anatomy, and software verification and validation. Mechanical testing showed implants withstand tensile and bending forces with expected deformation behaviors. Biocompatibility tests confirmed no cytotoxicity, sensitization, irritation, hemolysis, systemic toxicity, pyrogenicity, or neurotoxicity.
Predicate Devices
No predicate devices specified
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