Device Dossier

GMK Primary Cementless Tibial Tray Fixed - Coated knee tibia prosthesis

Device Dossier for GMK Primary Cementless Tibial Tray Fixed - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class III, sponsor Medacta).…

Intended purpose

GMK Standard Cementless Tibial Component forms part of the GMK Primary Knee System that is 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, and is available for primary and revision surgery. Candidates for the 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

The GMK Primary Fixed Cementless Tibial Tray is an asymmetric design which maximises bone coverage, assures optimal load distribution and avoids overhanging risk. The mirror polished surface of the tibial baseplate minimises backside wear, and the inlay clipping mechanism assures time-effective and safe implantation. The tibial tray is made from CoCrMo with UHMWPE plug, Ti coating, and HA coating.

TGA Public Summary