# K220880: Arthrex BioSuture

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Oct 27, 2022 after 216 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: 7 generations back to K990088 (1999). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112899: Arthrex Bio-Suture, Arthrex, Inc. (2012) Summary page 4.
- K140019: Arthrex Biosuture, Arthrex, Inc. (2014) Summary page 4.

## Indications for use
The Arthrex BioSuture is intended for soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs, including those with allograft or autograft tissues, are used for repair.

Source page: https://510kreport.com/device/K220880
Methodology: https://510kreport.com/methodology