Device Dossier

Apex Knee System, Revision Femur, PS, Cemented - Uncoated knee femur prosthesis

Device Dossier for Apex Knee System, Revision Femur, PS, Cemented - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor…

Intended purpose

The APEX Revision Femur PS is a sterile component of ‘The APEX Knee System’, which is intended for use as a primary or revision total knee replacement. The indications for use include: • Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; • Rheumatoid arthritis; • Correction of functional deformity; and • Revisions procedures where other treatments or devices have failed. The APEX Revision Knee System is designed to provide surgeons intra-operative versatility, allowing them to effectively provide patients with restored range of motion and pain relief.

Functional description

The APEX Revision Femur PS is made of CoCr and intended for cemented use. It is compatible with the APEX PS-R Tibial Inserts only, and provides fixation holes for the fixing of femoral augments when required.

TGA Public Summary