Device Dossier

Soft-tissue anchor, non-bioabsorbable

Device Dossier for Soft-tissue anchor, non-bioabsorbable (Soft-tissue anchor, non-bioabsorbable, Class IIb, sponsor Actis Medical). ARTG record, intended…

Intended purpose

The Grappler® Interference Screws are PEEK screws that are intended for soft tissue reattachment. The Grappler® Interference Screw implant is offered in various sizes to accommodate patient anatomy. The device is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue and tendon transfers in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist.

TGA Public Summary