Device Dossier

Biolox Delta - Link prosthesis head ceramic - Ceramic femoral head prosthesis

Device Dossier for Biolox Delta - Link prosthesis head ceramic - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor…

Intended purpose

Ceramic prosthesis head indicated for use in treatment of mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures • Primary and secondary coxarthrosis • Osteoarthritis • Necrosis of the femoral head • Femoral neck fractures • Revision after implant loosening

Functional description

The ceramic femoral prosthesis head replaces in combination with femoral stem and acetabular components the diseased hip joint. Key functional elements: - ceramic material - 12/14 mm taper connection for modular femoral stems - Different head diameters - Different head neck length for optimal adjustment

TGA Public Summary