# K191242: HEALIX ADVANCE SP BIOCOMPOSITE Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Aug 22, 2019 after 105 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 K961555 (1996). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
- K201883: 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor (2020), 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 SP BIOCOMPOSITE Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone: • Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair • Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral collateral ligament reconstruction, iliotibial (IT) band tenodesis • Foot/Ankle: Achilles tendon repair

Source page: https://510kreport.com/device/K191242
Methodology: https://510kreport.com/methodology