# K112249: Healix Knotless (TM) Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Oct 25, 2011 after 81 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: 7 generations back to K971358 (1997). 29 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family, Arthrex, Inc. (2006) Summary page 1.
- K073412: Gryphon BR and Healix BR Anchors, Depuy Mitek, A Johnson & Johnson Company (2008) Summary page 2.
- K032717: Biocryl Rapide Interference Screw, Mitek Worldwide (2004) Summary page 1.
- K060830: Milagro Interference Screw, Depuy Mitek, A Johnson & Johnson Company (2006) Summary page 1.
- K103831: Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809, Depuy Mitek, A Johnson & Johnson Company (2011) Summary page 1.

## Most influential descendants
- K130917: Healix Advance Knotless BR Anchor (2013), 9 descendants of its own
- K130539: Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM) (2013), 4 descendants of its own
- K131974: Healix Advance Knotless BR Anchor (6.5MM) (2013), 3 descendants of its own
- K131683: Healix Advance Knotless Peek Anchor (6.5MM) (2013), 3 descendants of its own
- K183501: Parcus Twist AP Suture Anchors (2019), 2 descendants of its own

## Indications for use
The Healix Knotless™ Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone: Shoulder * Rotator Cuff * Biceps Tenodesis

Source page: https://510kreport.com/device/K112249
Methodology: https://510kreport.com/methodology