Device Dossier

Biolox® Delta Ceramic Femoral Head - Ceramic femoral head prosthesis

Device Dossier for Biolox® Delta Ceramic Femoral Head - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor Zimmer…

Intended purpose

The Biolox delta Ceramaic Femoral Heads are modular components used in total hip arthroplasty and indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patientssuffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures

Functional description

A 12/14 tapered femoral head used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty to fit various patient anatomies and adjustment of the tension of the ligaments and reconstruction of the center of the natural head of the femur. Manufactured from material BIOLOX delta, an aluminum oxide matrix composite ceramic consisting of approx. 75% alumina (Al2O3), 24% zirconia (ZrO2) and trace elements. The pink color is due to Cr2O3.

TGA Public Summary