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…

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.

TGA Public Summary