# K112899: Arthrex Bio-Suture

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Apr 6, 2012 after 186 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: 5 generations back to K990088 (1999). 13 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041553: Arthrex Suture Grafting Kit, Arthrex, Inc. (2004) Summary page 1.
- K091018: Arthrex Biowire, Arthrex, Inc. (2010) Summary page 1.

## Most influential descendants
- K140019: Arthrex Biosuture (2014), 1 descendant of its own
- K223822: Activbraid™ (2023), 0 descendants of its own
- K220880: Arthrex BioSuture (2022), 0 descendants of its own

## Indications for use
The Arthrex Rio-Suture is intended for use in 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/K112899
Methodology: https://510kreport.com/methodology