Device Dossier
Genesis II All Polyethylene Posterior Stabilised Tibial Base - Uncoated knee tibia prosthesis, polyethylene
Device Dossier for Genesis II All Polyethylene Posterior Stabilised Tibial Base - Uncoated knee tibia prosthesis, polyethylene (Uncoated knee tibia…
- GMDN category: Uncoated knee tibia prosthesis, polyethylene
- Sponsor: Smith & Nephew
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. 5. 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 to replace tibial condyles of the knee joint. It is a one-piece contoured ultra-high molecular weight polyethylene tibial base designed to articulate with a posterior stabilized or constrained femoral component during knee joint replacement. It features structural posterior fins for additional rotational stability, an anatomically placed stem, and a dovetail waffle groove for cement interdigitation. It is intended for cemented use only.