Device Dossier

GMK Revision Tibial Tray Fixed TiNbN Coated Cemented - Uncoated knee tibia prosthesis, metallic

Device Dossier for GMK Revision Tibial Tray Fixed TiNbN Coated Cemented - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis,…

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 and is designed for cemented fixation. The fixed bearing tibial tray has a distal keel with two wings to increase the rotational stability. It is aimed to be assembled with cemented tibial augments.

TGA Public Summary