Device Dossier

BioComposite Tenodesis Screw - Fixation screw, bone, biodegradable

Device Dossier for BioComposite Tenodesis Screw - Fixation screw, bone, biodegradable (Fixation screw, bone, biodegradable, Class III, sponsor Arthrex).…

Intended purpose

The bioabsorbable fixation screws are intended to provide soft tissue reattachment, that is, fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, knee, foot/ankle and hand/wrist.

Functional description

A simple 'push-in' method facilitates accurate graft tensioning into the pre-drilled bone socket. The screw is then inserted (screwed in) into the socket. The construct allows for direct tendon-to-bone healing without hardware prominence.

TGA Public Summary