Device Dossier

BioComposite Tenodesis Screw with Handled Inserter - Fixation screw, bone, biodegradable

Device Dossier for BioComposite Tenodesis Screw with Handled Inserter - Fixation screw, bone, biodegradable (Fixation screw, bone, biodegradable, Class…

Intended purpose

The bioabsorbable fixation screws are intended to provide soft tissue reattachment, that is, fixation of ligament and tendon graft tissue is 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. The device is provided pre-mounted on a handled inserter.

TGA Public Summary