Device Dossier

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

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

Intended purpose

An uncemented porous Co-Cr-Mo alloy 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 tibial cruciate retaining components and, if required, patellar prosthetic components of the knee joint replacement. The internal surface of the femoral component has a sintered CoCr bead coating. 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