Device Dossier

Alumina Femoral Head - Ceramic femoral head prosthesis

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

Intended purpose

Hemi and total hip are 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) · Inflammatory arthropathy such as rheumatoid arthritis, or post traumatic arthritis · Metabolic arthropathy (chondro calcinosis) · Post traumatic degenerative arthritis · Avascular necrosis · Congenital 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 femoral heads are manufactured from pure alumina ceramic. They have a 12/14 internal taper for cementless fixation to the proximal stem and can be used to articulate against a polyethylene or ceramic acetabular liner.

TGA Public Summary