# K171296: SutureTape

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: May 26, 2017 after 24 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: 8 generations back to K904436 (1990). 32 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122374: Arthrex Suture (Uhmwpe), Arthrex, Inc. (2012) Summary page 4.

## Most influential descendants
- K193575: Arthrex SutureTape (2020), 1 descendant of its own
- K260018: Arthrex FiberButton (2026), 0 descendants of its own
- K221354: Arthrex SutureTape (2022), 0 descendants of its own

## Indications for use
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 tissue are used for repair.

Source page: https://510kreport.com/device/K171296
Methodology: https://510kreport.com/methodology