# K120078: Healix Advance BR Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek Inc., Johnson and Johnson Company
- Decided: Feb 29, 2012 after 50 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K971358 (1997). 27 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073412: Gryphon BR and Healix BR Anchors, Depuy Mitek, A Johnson & Johnson Company (2008) Summary page 1.
- 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, Depuy Mitek, A Johnson & Johnson Company (2010) Summary page 1.

## Most influential descendants
- 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
- K173859: HEALIX ADVANCE Anchor with DYNACORD Suture (2018), 4 descendants of its own
- K183506: HEALIX ADVANCE Anchor with DYNACORD Suture (2019), 2 descendants of its own
- K200949: HEALIX ADVANCE Anchor with DYNATAPE Suture (2020), 1 descendant of its own
- K170639: HEALIX ADVANCE Anchor with PERMATAPE Suture (2017), 1 descendant of its own

## Indications for use
The HEALIX ADVANCETM BR 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 Ligaament Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction; Hip: Capsular Repair, Acetabular Labral Repair.

Source page: https://510kreport.com/device/K120078
Methodology: https://510kreport.com/methodology