Device Dossier

Genesis II Mobile Bearing Articular Insert - Prosthesis, knee, internal, insert component

Device Dossier for Genesis II Mobile Bearing Articular Insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert…

Intended purpose

An UHMWPE articular insert used in conjunction with the GENESIS II knee system as part of a total knee prosthesis. Indications for Total Knee Replacement include: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement.

Functional description

An implantable device designed to articulate with the femoral component of a knee joint prosthesis during primary or revision knee joint replacement. It is a one-piece contoured ultra-high molecular weight polyethylene (UHMWPE) insert which locks into a tibial tray.

TGA Public Summary