# K180101: HEALIX ADVANCE KNOTLESS BR Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: May 10, 2018 after 114 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). 45 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171114: HEALIX ADVANCE KNOTLESS Anchor, Medos International SARL (2017) Summary page 4.
- K130917: Healix Advance Knotless BR Anchor, Depuy Mitek, A Johnson & Johnson Company (2013) Summary page 4.
- K131974: Healix Advance Knotless BR Anchor (6.5MM), Depuy Mitek, A Johnson & Johnson Company (2013) Summary page 4.
- K130539: Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM), Depuy Mitek, A Johnson & Johnson Company (2013) Summary page 4.
- K131683: Healix Advance Knotless Peek Anchor (6.5MM), Depuy Mitek, Inc., A Johnson and Johnson Company (2013) Summary page 4.
- K101679: Arthrex Pushlock Anchors, Arthrex, Inc. (2010) Summary page 4.
- K082810: Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak and Bio-Composite Corkscrew, Arthrex, Inc. (2009) Summary page 4.
- K071177: Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak, Bio-Composite Corkscrew, Arthrex, Inc. (2007) Summary page 4.
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family, Arthrex, Inc. (2006) Summary page 4.
- K051219: Pushlock, Arthrex, Inc. (2005) Summary page 4.

## Most influential descendants
- K241010: HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors (2024), 0 descendants of its own

## 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, Deltoid Repair Knee: Posterior Oblique, Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), Iliotibial (IT) Band Tenodesis Foot/Ankle: Achilles Tendon Repair

Source page: https://510kreport.com/device/K180101
Methodology: https://510kreport.com/methodology