Device Dossier

Orthopaedic prosthesis implantation instrument, single-use

Device Dossier for Orthopaedic prosthesis implantation instrument, single-use (Orthopaedic prosthesis implantation instrument, single-use, Class IIa,…

Intended purpose

A device intended to be used during implantation of an orthopaedic prosthesis to aid in the navigation/placement of the prosthesis or other instruments. It may be used to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component, to provide relative position landmarks, to ascertain correct spatial orientation, and/or to interface between prosthesis components.

TGA Public Summary