# K113534: Healix Knotless Anchor

- Pathway: 510(k) (Special)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Dec 20, 2011 after 20 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: 11 generations back to K971358 (1997). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112249: Healix Knotless (TM) Anchor, Depuy Mitek, A Johnson & Johnson Company (2011) Summary page 2.
- K103712: Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord, Depuy Mitek, A Johnson & Johnson Company (2011) Summary page 1.
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family, Arthrex, Inc. (2006) Summary page 1.

## 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/K113534
Methodology: https://510kreport.com/methodology