Device Dossier
Genesis II Posterior Stabilised Porous Femoral Component - Coated knee femur prosthesis
Device Dossier for Genesis II Posterior Stabilised Porous Femoral Component - Coated knee femur prosthesis (Coated knee femur prosthesis, Class III,…
- GMDN category: Coated knee femur prosthesis
- Sponsor: Smith & Nephew
Intended purpose
An uncemented porous Co-Cr-Mo alloy posterior stabilised 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. 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 designed to replace the femoral condyles during knee joint replacement. The device articulates with a posterior stabilised (PS) tibial insert and, if required, patellar prosthetic components of the knee joint. 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 bone cement.