Device Dossier
LEGION CoCr Constrained Femoral Component - Uncoated knee femur prosthesis
Device Dossier for LEGION CoCr Constrained Femoral Component - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor Smith &…
- GMDN category: Uncoated knee femur prosthesis
- Sponsor: Smith & Nephew
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.