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 sterile surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: They are attached to given surgical instruments to provide the required orientation information for the cutting plans.

TGA Public Summary