TECHFIT DISRP® System

The TECHFIT DISRP System is a web-based software platform for digital surgical planning in maxillofacial and reconstruction surgeries. It processes CT/CBCT imaging data to generate patient-specific surgical guides, splints, and anatomical models made from titanium or resin, intended for use in orthognathic and reconstructive procedures in adults.

The device includes Anatomic Specificx Reconstruction Guides (CP titanium, machined) and Palatal Splints (CP titanium). Key software functions are 3D visualization, distance/angle measurements, bone fragment manipulation for surgical planning, 3D cephalometry, and export of surgical guide/splint designs. Software accepts DICOM and STL file formats and outputs encrypted STL files. Contact duration for splints is prolonged (24–30 days); for reconstruction guides, limited (≤24 hours).

AAMI/ISO 17665-1:2006(R)2013 (steam sterilization validation), ANSI/AAMI/ISO 14937:2009(R)2013 (sterilization process characterization), ISO 10993-3, 10993-5, 10993-10, 10993-11, 10993-17, 10993-18, and ISO 10993-23 (biocompatibility—cytotoxicity, sensitization, irritation, acute toxicity, pyrogenicity, genotoxicity, and chemical characterization).

The predicate KLS Martin IPS Planning System performs identical functions (software-based surgical planning, 3D modeling, guide/splint design) for the same indications (maxillofacial and reconstruction surgeries). Both are patient-specific devices processing CT imaging, accepting DICOM/STL inputs, and producing surgical guides and splints for maxillofacial use. Materials are biocompatible titanium and compatible resins; sterilization is steam-based. Non-clinical testing confirms dimensional accuracy, mechanical performance superior to predicate plates, successful compatibility with companion systems, and adequate biocompatibility. The addition of reconstruction guide visualization and fibula graft/flap features represent functional enhancements to an existing category of devices using established technology and manufacturing methods.