# K041216: Smith & Nephew Ultrabraid Suture

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 7, 2004 after 28 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: 1 generation back to K033654 (2004). 2 ancestors in all.
16 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033654: Force Fiber, Teleflex Medical (2004) Summary page 1.
- K040472: Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical Suture, Teleflex Medical (2004) Summary page 1.

## Most influential descendants
- K121861: Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB Meniscal Repair System, Smith & N (2012), 12 descendants of its own
- K190125: FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire (2019), 2 descendants of its own
- K221731: FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire (2022), 1 descendant of its own
- K203393: Fast-Fix Flex (2021), 1 descendant of its own
- K153667: TRUESPAN Meniscal Repair System (2016), 1 descendant of its own

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

Source page: https://510kreport.com/device/K041216
Methodology: https://510kreport.com/methodology