Device Dossier
BIOLOX®OPTION Modular Ti-Sleeve - Femoral head/stem prosthesis adaptor
Device Dossier for BIOLOX®OPTION Modular Ti-Sleeve - Femoral head/stem prosthesis adaptor (Femoral head/stem prosthesis adaptor, Class III, sponsor Smith…
- GMDN category: Femoral head/stem prosthesis adaptor
- Sponsor: Smith & Nephew
Intended purpose
BIOLOX®OPTION metal sleeves are intended to be used as primary or revision hip joint replacement. Advanced degeneration of the hip joint as result of osteoarthritis, avascular necrosis, posttraumatic arthritis, or rheumatoid arthritis Conditions resulting from previous operations of the hip joint, such as failed total hip prosthesis
Functional description
The BIOLOX®OPTION titanium sleeve is to be used with the BIOLOX OPTION femoral heads. The intraoperatively assembled ball head is matched with the metal sleeve of the BIOLOX®OPTION System are firmly attached to the taper of a metallic femoral hip stem prosthesis. The BIOLOX®OPTION titanium sleeve is placed on the taper to reduce the effects of taper unevenness and creates a smooth taper surface for the ceramic head.