Device Dossier

Healix Advance Knotless PEEK Anchor - Soft-tissue anchor, non-bioabsorbable

Device Dossier for Healix Advance Knotless PEEK Anchor - Soft-tissue anchor, non-bioabsorbable (Soft-tissue anchor, non-bioabsorbable, Class III, sponsor…

Intended purpose

The HEALIX Advance Knotless PEEK Anchors are indicated for use in soft tissue to bone fixation as follows: Shoulder: Rotator Cuff Repair, Biceps Tenodesis, Deltoid Repair. Foot/Ankle: Achilles Tendon.

Functional description

Healix Advance Knotless PEEK (Polyetheretherketone) Anchors are one piece sterile implants 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