Device Dossier

GMK Sphere Primary E-Cross Resurfacing Patella Cemented - Polyethylene patella prosthesis

Device Dossier for GMK Sphere Primary E-Cross Resurfacing Patella Cemented - Polyethylene patella prosthesis (Polyethylene patella prosthesis, Class III,…

Intended purpose

Device intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint, if there is evidence of sufficient sound bone to seat and support the components. Candidates for total or unicompartmental knee replacement are patients with a severely painful and/or severely disabled joint as a result of osteoarthritis, post-traumatic arthritis, rheumatoid polyarthritis, or primary implantation failure.

Functional description

The Resurfacing E-Cross Patella is manufactured from Vitamin E Highly Crosslinked UHMWPE and is intended to replace the damaged surface of the natural patella (knee cap). It is designed to articulate with a prosthetic femoral component.

TGA Public Summary