Device Dossier

Active Knee Patella Implant - Polyethylene patella prosthesis

Device Dossier for Active Knee Patella Implant - Polyethylene patella prosthesis (Polyethylene patella prosthesis, Class III, sponsor Signature…

Intended purpose

The patella implant is a component of the Active Knee System. The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support prosthesis. It is intended for Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; Inflammatory degenerative joint disease including rheumatoid arthritis; Functional deformity such as varus, valgus or flexion deformities; Revision procedures where other treatments or devices have failed; Fractures that are unmanageable using other techniques.

Functional description

The patella component manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE) and has a dome shape with the reverse curvature of the femoral condyles. The patella is designed for fixation with PMMA - cement. The patella component is available in several sizes to suit different anatomies.

TGA Public Summary