Device Dossier

Healix Advance PEEK Anchor with Orthocord - Anchor, bone-implanted, soft-tissue, non-biodegradable

Device Dossier for Healix Advance PEEK Anchor with Orthocord - Anchor, bone-implanted, soft-tissue, non-biodegradable (Soft-tissue anchor,…

Intended purpose

The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation in association with post-operative immobilisation as follows: Shoulder - Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle - Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair. Knee - Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Elbow - Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip - Capsular repair, acetabular labral repair.

Functional description

Healix Advance PEEK anchor with orthocord comprises a non-absorbable polyetheretherketone (PEEK) threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of two or three strands of #2 absorbable Orthocord suture to bone. The implant is supplied sterile ready to use.

TGA Public Summary