# K132357: Smith & Nephew Ultratape

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 30, 2013 after 93 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: 3 generations back to K033654 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101377: Smith & Newphew Ultrabraid II Suture, Smith & Newphew, Inc. (2011) Summary page 1.
- K041216: Smith & Nephew Ultrabraid Suture, Smith & Nephew, Inc. (2004) Summary page 2.

## Indications for use
Smith & Nephew ULTRATAPE is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries.

Source page: https://510kreport.com/device/K132357
Methodology: https://510kreport.com/methodology