# K130917: Healix Advance Knotless BR Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: May 24, 2013 after 51 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K971358 (1997). 30 ancestors in all.
9 later devices descend from it; 6 cite it directly.
0 of 40 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 1.

## Most influential descendants
- K131974: Healix Advance Knotless BR Anchor (6.5MM) (2013), 3 descendants of its own
- K183501: Parcus Twist AP Suture Anchors (2019), 2 descendants of its own
- K171114: HEALIX ADVANCE KNOTLESS Anchor (2017), 2 descendants of its own
- K212381: VersaTap, VersaLat, DueLock, VersaTi, MiniTi (2021), 1 descendant of its own
- K180101: HEALIX ADVANCE KNOTLESS BR Anchor (2018), 1 descendant of its own

## Recalls of this device
- Nov 4, 2019 · Class II · Z-0665-2020: Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE Biocomposite Material. BIOCRYL and BIOCRYL
- Nov 4, 2019 · Class II · Z-0666-2020: Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE Biocomposite Material. BIOCRYL and BIOCRYL

## Indications for use
The HEALIX ADVANCE KNOTLESS BR 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/K130917
Methodology: https://510kreport.com/methodology