Device Dossier
Biolox® Option Femoral Head and Adapter 12/14 - Ceramic femoral head prosthesis
Device Dossier for Biolox® Option Femoral Head and Adapter 12/14 - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor…
- GMDN category: Ceramic femoral head prosthesis
Intended purpose
The ceramic femoral heads are intended to be used as a modular component in conjunction with a cup or insert for articulation in total hip arthroplasty. Total Hip Arthroplasty is indicated for 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; patients suffering 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
Ceramic femoral head component used in conjunction with an adapter made of titanium alloy with an inner taper to interlock it with femoral stems with corresponding tapers, and a ceramic femoral head with a taper to match the outer taper of the head adapter. Ceramic femoral heads are to be used in combination with PE or with suitable ceramic inserts/cups.