Device Dossier

Genesis II Cruciate Retaining All Polyethylene Tibial Base - Uncoated knee tibia prosthesis, polyethylene

Device Dossier for Genesis II Cruciate Retaining All Polyethylene Tibial Base - Uncoated knee tibia prosthesis, polyethylene (Uncoated knee tibia…

Intended purpose

1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed, unicompartmental replacement, or total knee replacement.

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 cruciate retaining 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.

TGA Public Summary