Device Dossier

Alumina Composite Femoral Head - Ceramic femoral head prosthesis

Device Dossier for Alumina Composite Femoral Head - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor Evolutis MA).…

Intended purpose

The alumina/zirconia composite femoral head is indicated for the treatment of symptomatic pain and/or functional problems of the hip in patients whose skeleton is mature and only when pain killers and conservative treatment used correctly have failed. The anatomy and structure of the patients articulation will need to be adapted to receive the selected implant(s). The most frequent indications for total or partial hip arthroplasty are: - Degenerative non inflammatory arthropathy (osteoarthritis of the hip or knee) - Inflammatory arthropathy such as rheumatoid arthritis, or post traumatic arthritis - Metabolic arthropathy (chondo calcinosis) - Post Traumatic degenerative arthritis - Avascular necrosis - Congential dysplasia of the hip - Functional repair of a recent trauma (fracture, dislocation) - Revision of a previous failed partial or total arthroplasty - Complications related to peri articular bone tumours

Functional description

The alumina composite femoral head is manufactured from alumina/zirconia composite ceramic. They have a 12/14 internal taper, and are designed to articulate against a polyethylene or ceramic acetabular component. The femoral heads are attached to the stems via non-cemented use.

TGA Public Summary