# K101377: Smith & Newphew Ultrabraid II Suture

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Newphew, Inc.
- Decided: Apr 8, 2011 after 326 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: 2 generations back to K033654 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K132357: Smith & Nephew Ultratape (2013), 0 descendants of its own

## Indications for use
The Smith & Nephew ULTRABRAID TM 11Suture is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries.

Source page: https://510kreport.com/device/K101377
Methodology: https://510kreport.com/methodology