TECHFIT DISRP® System
TECHFIT Digital Surgery Inc.The TECHFIT DISRP® System is a digital surgery platform designed to help clinicians plan and simulate maxillofacial surgeries. It processes CT scan data to create 3D models and surgical guides or splints that assist surgeons during operations by translating imaging information into physical tools for improved surgical precision and patient-specific treatment.
Intended Use
TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System is intended for use as a software system and image segmentation system for transfer of imaging information from a medical scanner such as a CT based system, processing input data file and outputting digital models or physical surgical guides and splints for maxillofacial surgery. It is also a preoperative software tool for simulating and evaluating surgical treatment options compatible with patient-specific maxillofacial systems and diagnostic models.
Technology
The system is a web-based collaboration platform integrating digital surgery case management and planning for orthognathic and reconstructive maxillofacial surgeries. It produces patient-specific surgical guides and splints using stereolithography and machining with materials such as titanium and resin. It supports multiple users and devices for planning, exporting designs for production, and includes visualization and measurement tools for surgical planning.
Performance
Non-clinical testing included sterilization validation, dimensional validation comparing scanned guides to design files, compatibility testing with related maxillofacial systems, mechanical testing of plates, software verification and validation, and biocompatibility evaluations showing no cytotoxicity or sensitization. The data support substantial equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/1/2024
4 months - 2
FDA Approval
12/11/2024
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