# K193575: Arthrex SutureTape

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jul 24, 2020 after 214 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: 9 generations back to K904436 (1990). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171296: SutureTape, Arthrex, Inc. (2017) Summary page 4.

## Most influential descendants
- K260018: Arthrex FiberButton (2026), 0 descendants of its own

## Indications for use
The Arthrex SutureTape 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/K193575
Methodology: https://510kreport.com/methodology