# K120449: Healix Advance Peek Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek
- Decided: May 11, 2012 after 87 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K021883 (2002). 5 ancestors in all.
50 later devices descend from it; 4 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071481: Healix Anchor, Depuy Mitek, A Johnson & Johnson Company (2007) Summary page 1.

## Most influential descendants
- K133636: Extremity Medical Hammertoe Device (2014), 31 descendants of its own
- K141857: CrossTie Intraosseous Fixation System (2015), 16 descendants of its own
- K151270: CrossTIE Intraosseous Fixation System (2015), 15 descendants of its own
- K181872: MIS Bunion System (2019), 14 descendants of its own
- K133794: 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix Advance BR Anchor, with 2 or 3 (2014), 8 descendants of its own

## Indications for use
The HEALIX ADVANCE™ PEEK Anchor is indicated for: 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.

Source page: https://510kreport.com/device/K120449
Methodology: https://510kreport.com/methodology