Device Dossier

Anchor, soft-tissue implanted, non-biodegradable

Device Dossier for Anchor, soft-tissue implanted, non-biodegradable (Anchor, soft-tissue implanted, non-biodegradable, Class IIb, sponsor Integrant).…

Intended purpose

This product features a titanium corkscrew anchor with ultra-high molecular weight polyethylene suture (fibre). Disposable insertion tool consists of handle and stainless steel. The implant is designed to pass through the ropes. The anchor is a fully threaded corkscrew design to obtain maximum purchase and hold in soft cancellous bone.This product is designed for use in tendon and ligament repair surgeries. Ankle Brostrom lateral ankle ligament stabilisation Achilles tendon repairs, Metatarsal ligament and tendon repair Hand/Wrist Scapholunate ligament reconstruction Ulna or radial collateral ligament reconstruction Knee Tendon Repair Repair of internal and external lateral ligaments Shoulder Rotator cuff repair Bicep tendon Repair of deltoid

TGA Public Summary