Device Dossier

Orthopaedic implantation application software

Device Dossier for Orthopaedic implantation application software (Orthopaedic implantation application software, Class IIa, sponsor DePuy Synthes). ARTG…

Intended purpose

An individual software application program that adds specific computer-assisted display, processing, and/or analysis capabilities to a computer to simulate/evaluate implant placement and surgical treatment options. Using CT and/or MRI images, it can zoom, measure, and annotate 3D planned images in order to determine an appropriate surgical plan. The plan may be used to create a custom surgery guide.

TGA Public Summary