Device Dossier

Biolox Delta Ceramic Femoral Head 12/14 Taper - Ceramic femoral head prosthesis

Device Dossier for Biolox Delta Ceramic Femoral Head 12/14 Taper - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor…

Intended purpose

Femoral Heads are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis. Femoral Heads are indicated for individuals for inflammatory degenerative joint disease including rheumatoid arthritis; congenital dysplasia; femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; and fracture dislocation of the hip.

Functional description

A sterile implantable artificial femoral head that is made of an alumina zirconia material composite designed to mate with a hip stem through a corresponding 12/14 taper and to articulate with an acetabular prosthesis as part of total hip arthroplasty. Following a trial reduction with a femoral head trial, the neck taper of the stem is wiped clean with a sterile cloth and the femoral head is placed onto the neck taper and firmly impacted with a mallet.

TGA Public Summary