Device Dossier
BIOSURE HA - Fixation screw, bone, biodegradable
Device Dossier for BIOSURE HA - Fixation screw, bone, biodegradable (Fixation screw, bone, biodegradable, Class III, sponsor Smith & Nephew). ARTG…
- GMDN category: Fixation screw, bone, biodegradable
- Sponsor: Smith & Nephew
Intended purpose
A device intended for fixation of bone-tendon-bone or soft tissue grafts during anterior/posterior cruciate ligament (ACL/PCL) reconstruction procedures.
Functional description
Single use headless cannulated interference screw made from absorbable polylactic acid (PLLA) and hydroxyapatite (HA) designed to maintain adequate fixation strength until healing occurs.