Device Dossier

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

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

Intended purpose

BIOLOX delta ceramic ball heads are intended to be used in total or partial hip replacement procedures, in combination with a femoral stem providing 12/14 morse-taper, coupling with a bi-articular head or an acetabular cup and related insert (in UHMWPE or BIOLOX forte / BIOLOX delta alumina). Indications for use are advanced wear of the joint due to dysplasia, degenerative, post-traumatic, or rheumatic diseases, fractures or avascular necrosis, negative outcome of precedent surgeries such as joint reconstruction, osteotomies, arthrodesis, hemi-arthroplasty or total hip prosthesis.

Functional description

Biolox Delta ceramic femoral heads are available in 3 neck lengths and are to be used exclusively with polyethylene liners and ceramic Biolox inserts. BIOLOX articular heads ensure a very low level of wear thanks to high corrosion resistance, material biocompatibility, degree of hardness, dimensional stability of the components and to excellent wetting and low roughness of surfaces.

TGA Public Summary