Device Dossier

Genesis II Nonporous Posterior Stabilised Femoral Component - Uncoated knee femur prosthesis

Device Dossier for Genesis II Nonporous Posterior Stabilised Femoral Component - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class…

Intended purpose

1.Rheumatoid arthritis. 2.Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3.Failed, unicompartmental replacement, or total knee replacement. 4.Posterior stabilized 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 (femoral component) during primary replacement of the knee joint. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint. Following resection of the femur, the femoral component is intended to be implanted with bone cement.

TGA Public Summary