# K221354: Arthrex SutureTape

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Sep 9, 2022 after 122 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.
No later device cites it as a predicate yet.
0 of 34 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.

## Indications for use
The Arthrex SutureTape is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

Source page: https://510kreport.com/device/K221354
Methodology: https://510kreport.com/methodology