Device Dossier

Genesis II HA Porous Tibial Base - Coated knee tibia prosthesis

Device Dossier for Genesis II HA Porous Tibial Base - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class III, sponsor Smith & Nephew).…

Intended purpose

A porous HA coated titanium alloy tibial baseplate component used in conjunction with the Genesis II total knee system. Indications for use include rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement or total knee replacement. Posterior stabilised knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

Functional description

A sterile implantable device to replace tibial condyles of the knee joint. The titanium tibial base is designed to hold an insert which articulates with a cruciate retaining, posterior stabilised, or constrained femoral, dependent on the insert choice. The porous baseplate incorporates fins, spikes, and screws for increased fixation. The porous surface of the tibial tray has a sintered bead coating and a coating of non-animal derived HA. It is intended to be used without cement.

TGA Public Summary