Device Dossier

Genesis II Cruciate Retaining HA Porous Femoral Component - Coated knee femur prosthesis

Device Dossier for Genesis II Cruciate Retaining HA Porous Femoral Component - Coated knee femur prosthesis (Coated knee femur prosthesis, Class III,…

Intended purpose

An uncemented Co-Cr-Mo alloy porous HA cruciate retaining femoral 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.

Functional description

A sterile implantable device designed to replace the femoral condyles during knee joint replacement. The device articulates with cruciate retaining tibial inserts and, if required, patellar prosthetic components of the knee joint. The internal surface of the femoral component has a sintered CoCr bead coating and a coating of non-animal derived hydroxyapatite. Flex-Lok pegs or finned lugs are added for stability and increased pullout strength. It is intended to be used without cement.

TGA Public Summary