Device Dossier

Healix Advance BR Anchor with Dynacord Suture, with Needles - Fixation anchor, soft-tissue, biodegradable

Device Dossier for Healix Advance BR Anchor with Dynacord Suture, with Needles - Fixation anchor, soft-tissue, biodegradable (Fixation anchor,…

Intended purpose

The HEALIX Advance BR Anchor with Dynacord Suture, with needles, is intended for soft tissue to bone reattachment in the following procedures: Shoulder: Rotator Cuff Repair, Biceps Tenodesis.

Functional description

BR (Biocryl Rapide) is a composite (PLGA/TCP) absorbable threaded suture anchor preloaded on a disposable inserter and assembly intended for fixation of two or three strands of #2 Dynacord suture, to bone. The Dynacord suture has stainless steel needles attached. The implant is supplied sterile ready to use.

TGA Public Summary