Device Dossier
Orthopaedic implantation application software
Device Dossier for Orthopaedic implantation application software (Orthopaedic implantation application software, Class IIa, sponsor Formus Labs). ARTG…
- GMDN category: Orthopaedic implantation application software
Intended purpose
Formus Hip is a software product of the Formus Platform intended to provide orthopaedic surgeons or other trained healthcare professionals information about the fit of orthopaedic implants for primary total hip arthroplasty (THA). The software is intended to read in and interpret patient diagnostic imaging studies, simulate the fit of an in-built library of orthopaedic implants to the patient anatomy in the scans, and display information about the fit of each implant to the user in a graphical user interface and a printable report. The software is intended to be used on the scans of patients indicating a need for primary THA.