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…
- GMDN category: Ceramic femoral head prosthesis
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.