Device Dossier

C-TAPER BIOLOX DELTA CERAMIC HEAD - Ceramic femoral head prosthesis

Device Dossier for C-TAPER BIOLOX DELTA CERAMIC HEAD - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor Stryker).…

Intended purpose

An implantable ball-shaped component used to replace the anatomical femoral head and intended to attach to the grunion of a femoral stem component used in a total or hemi hip joint replacement. Indication: 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

A sterile implantable ball-shaped component used to replace the anatomical Femoral Head. Intended to fit on the trunnion of a Femoral Hip Stem and articulate with an artificial Acetabular Component. Made of Zirconia Toughened Alumina. Comes in a range of sizes to suit patient anatomical requirements.

TGA Public Summary