# K212146: Arthrex LoopLoc Knotless Suture

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Oct 25, 2021 after 108 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K904436 (1990). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122374: Arthrex Suture (Uhmwpe), Arthrex, Inc. (2012) Summary page 4.
- K041553: Arthrex Suture Grafting Kit, Arthrex, Inc. (2004) Summary page 4.

## Indications for use
The Arthrex LoopLoc™ Knotless Suture is intended for soft-tissue approximation for hip capsular closure.

Source page: https://510kreport.com/device/K212146
Methodology: https://510kreport.com/methodology