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,…
- GMDN category: Orthopaedic prosthesis implantation instrument, single-use
Intended purpose
A sterile, hand-held 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: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a single-use device.