Device Dossier

V40 Taper BIOLOX Delta Ceramic Femoral Head - Ceramic femoral head prosthesis

Device Dossier for V40 Taper BIOLOX Delta Ceramic Femoral Head - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor…

Intended purpose

An implantable ball-shaped component used to replace the anatomical femoral head and intended to attach to the trunnion of a femoral stem component. Indications: • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. • Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. • Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. • Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum

Functional description

BIOLOX delta ceramic femoral head is a biocomposite Alumina Matrix Composite (AMC) material. A ball-shaped component used to replace the anatomical femoral head and designed for assembly through a taper lock mechanism, to the trunnion of a V40 taper femoral stem. The femoral head comes in a variety of diameters and neck offsets to meet various patient anatomical requirements.

TGA Public Summary