# K190707: Arthrex SoftStitch

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Oct 2, 2020 after 563 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: 6 generations back to K925573 (1993). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132043: Arthrex Speedcinch, Arthrex, Inc. (2013) Summary page 4.
- K073149: Meniscal Cinch, Arthrex, Inc. (2008) Summary page 4.

## Most influential descendants
- K243480: SuturePatch Tissue Reinforcement (2025), 0 descendants of its own
- K222078: Arthrex SoftStitch (2022), 0 descendants of its own

## Indications for use
The Arthrex SoftStitch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.

Source page: https://510kreport.com/device/K190707
Methodology: https://510kreport.com/methodology