Device Dossier

APEX Primary Knee System ECiMa All Poly Patella 3 Peg - Polyethylene patella prosthesis

Device Dossier for APEX Primary Knee System ECiMa All Poly Patella 3 Peg - Polyethylene patella prosthesis (Polyethylene patella prosthesis, Class III,…

Intended purpose

The APEX Primary Knee All Poly Patella 3 Peg is a component of the Apex Knee System intended to replace the patella articular surface of the knee joint in a primary or revision total knee replacement. This prosthesis may be used for the following conditions as appropriate: o Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; o Rheumatoid arthritis; o Correction of functional deformity and o Revision procedures where other treatments or devices have failed.

Functional description

The APEX Primary Knee All Poly Patella 3 Peg component is designed to replace the patella articular surface of the patient. It articulates against the femoral component in the APEX Primary Knee System. The device is made from ECiMa polyethylene and is intended for cemented use in the APEX Primary Knee System only.

TGA Public Summary