Device Dossier

Active Knee Femoral Implant, Cementless - Coated knee femur prosthesis

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

Intended purpose

The cementless femoral 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 mecrosis; 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 sing 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 femoral implant is available in several sizes to suit different anatomies. The interior of the cementless femoral implant has a hydroxyapatite coating with a beaded distal surface to encourage bony ingrowth on the prosthesis.

TGA Public Summary