Device Dossier

Biolox Delta Ball Head - Ceramic femoral head prosthesis

Device Dossier for Biolox Delta Ball Head - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor Medacta). ARTG record,…

Intended purpose

BIOLOX delta ball heads to be placed on endoprosthesis stems with a congruent taper in primary and revision hip surgery. Total hip arthroplasty is suitable in the following cases: Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia, Avascular necrosis of the femoral head, Acute traumatic fracture of the femoral head or neck, Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty

Functional description

BIOLOX 12/14 delta ball heads, made from high-purity alumina ceramic compound, reduce polyethylene abrasion in combination with polyethylene cups or cup inserts. Only to be combined with components from the manufacturer for use with BIOLOX delta ball heads and used with prosthesis types that have identical taper measurements within the specified tolerances. The taper clamp allows a reliable and tension resistant placement and causes force to be spread equally from the ball head to the stem.

TGA Public Summary