Device Dossier

GMK Revision SC Peg TiNbN Coated - Prosthesis, knee, internal, insert component

Device Dossier for GMK Revision SC Peg TiNbN Coated - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert component, Class…

Intended purpose

Device intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint, if there is evidence of sufficient sound bone to seat and support the components. Candidates for total knee replacement are patients with a severely painful and/or severely disabled joint as a result of osteoarthritis, post-traumatic arthritis, rheumatoid polyarthritis, or primary implantation failure.

Functional description

Device is manufactured from cobalt chrome with TiNbN coating. The SC Peg designed to fix the SC fixed insert to the tibial tray. It is designed to be assemble only in combination with the SC insert.

TGA Public Summary