Device Dossier

BioComposite Tenodesis Screw with Disposable Driver Pack - Fixation screw, bone, biodegradable

Device Dossier for BioComposite Tenodesis Screw with Disposable Driver Pack - Fixation screw, bone, biodegradable (Fixation screw, bone, biodegradable,…

Intended purpose

A BioComposite Tenodesis Screw with Disposable Driver Pack is intended to be used for fixation of tissue, including ligament or tendon to bone 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 graft-to-bone healing without hardware prominence. The device is provided pre-mounted on a handled inserter and passing suture.

TGA Public Summary