# K131974: Healix Advance Knotless BR Anchor (6.5MM)

- Pathway: 510(k) (Special)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Jul 25, 2013 after 27 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). 31 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130917: Healix Advance Knotless BR Anchor, Depuy Mitek, A Johnson & Johnson Company (2013) Summary page 1.

## Most influential descendants
- K171114: HEALIX ADVANCE KNOTLESS Anchor (2017), 2 descendants of its own
- K180101: HEALIX ADVANCE KNOTLESS BR Anchor (2018), 1 descendant of its own
- K241010: HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors (2024), 0 descendants of its own

## Indications for use
The Healix Advance Knotless Anchors are 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/K131974
Methodology: https://510kreport.com/methodology