Device Dossier

FastThread BioComposite Interference Screw - Fixation screw, bone, biodegradable

Device Dossier for FastThread BioComposite Interference Screw - Fixation screw, bone, biodegradable (Fixation screw, bone, biodegradable, Class III,…

Intended purpose

The FastThread BioComposite Interference Screw is intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone or soft tissue grafts during anterior cruciate ligament repair.

Functional description

The FastThread BioComposite Interference Screw is comprised of PLLA or PLDLA, Biphasic Calcium Phosphate. Fast and easy insertion are attributed by the implants prominent thread pitch. The vented design reduces material implanted and allows bony ingrowth which promotes absorption. The screw provides the necessary pull-out strength during healing

TGA Public Summary