Device Dossier

Healix Advance Knotless BR Anchor - Fixation anchor, soft-tissue, biodegradable

Device Dossier for Healix Advance Knotless BR Anchor - Fixation anchor, soft-tissue, biodegradable (Fixation anchor, soft-tissue, biodegradable, Class…

Intended purpose

Healix Advance Knotless BR Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone as follows: Shoulder: Rotator Cuff and Biceps Tenodesis.

Functional description

The HEALIX Advance Knotless BR Anchors are one piece sterile implants consisting of Biocryl Rapide (BR), an absorbable composite material. They are designed to secure soft tissue to bone when used in conjunction with high strength partially absorbable #2 Orthocord synthetic stay suture or PERMATAPE 2.5mm suture (not included). Each device includes a suture anchor, the inserter assembly (i.e., shaft, handle, driver collar, threader tab) and one #2 Orthocord suture.

TGA Public Summary