Device Dossier

LEGION OXINIUM Constrained Femoral Component - Uncoated knee femur prosthesis

Device Dossier for LEGION OXINIUM Constrained Femoral Component - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor…

Intended purpose

Indications for Total Knee Replacement Include- 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. 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. 4. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.

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