Device Dossier

Active Knee Femoral Implant, Cemented - Uncoated knee femur prosthesis

Device Dossier for Active Knee Femoral Implant, Cemented - Uncoated knee femur prosthesis (Uncoated knee femur prosthesis, Class III, sponsor Signature…

Intended purpose

The cemented femoral implant is a part of the Active Knee System for skeletally mature patients which have adequate bone stock. 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 femoral component is an anatomic, asymmetrically designed prosthesis manufactured from cast cobalt-chromium-molybdenum (CoCrMo). The design incorporates a trochlear groove, which conforms to the geometry of the patellar prosthesis and allows for sliding articulation. The cemented femoral implant has a grit blast finish on the interior surfaces for enhanced polymethylmethacrylate (PMMA) fixation.

TGA Public Summary