# K071481: Healix Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Aug 9, 2007 after 72 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: 2 generations back to K021883 (2002). 4 ancestors in all.
99 later devices descend from it; 6 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041069: Spiralok Anchor, Depuy Mitek, A Johnson & Johnson Company (2004) Summary page 1.
- K060271: Spiralok Anchor, Depuy Mitek, A Johnson & Johnson Company (2006) Summary page 1.

## Most influential descendants
- K120449: Healix Advance Peek Anchor (2012), 50 descendants of its own
- K073412: Gryphon BR and Healix BR Anchors (2008), 44 descendants of its own
- K133636: Extremity Medical Hammertoe Device (2014), 31 descendants of its own
- K090124: Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814 (2009), 25 descendants of its own
- K100012: Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS Anchor W/Orthocord, Gryphon P BR a (2010), 24 descendants of its own

## Indications for use
Healix Anchor is indicated for use in the following: Shoulder: Rotor 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/K071481
Methodology: https://510kreport.com/methodology