Device Dossier
BioComposite Interference Screw - Fixation screw, bone, biodegradable
Device Dossier for BioComposite Interference Screw - Fixation screw, bone, biodegradable (Fixation screw, bone, biodegradable, Class III, sponsor…
- GMDN category: Fixation screw, bone, biodegradable
Intended purpose
Intended to provide interference fixations of bone-tendon-bone or soft tissue grafts during ACL reconstruction.
Functional description
The BioComposite Interference Screw is comprised of TCP, PLDLA and HA. Significant strength is added to the implant by virtually eliminating stress risers while creating a macro and micro porous matrix to aid in the bone remodeling and replacement process. The screw provides the necessary pull-out strength during the healing period and is absorbed.