510(k) · Cleared

Cleared

Smith & Nephew Ultrabraid Suture

K041216510(k) AbbreviatedCleared Jun 7, 200428-day reviewClass II21 CFR 878.5000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Jun 7, 2004 as substantially equivalent to K033654 (Teleflex Medical, 2004) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 2004. 16 later devices descend from it.

Decided: Jun 7, 2004
Review: 28 days
Class: Class II
Product code: GAT
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K033654 (2004). 2 ancestors in all. 16 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK033654 Force FiberTeleflex Medical · 2004
This deviceK041216 Smith & Nephew Ultrabraid SutureSmith & Nephew, Inc. · 2004
Descendant · cites it directly · 12 of its ownK121861 Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew…Smith & Nephew, Inc. · 2012
Descendant · 2 generations on · 2 of its ownK190125 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2019
Descendant · 3 generations on · 1 of its ownK221731 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2022
Descendant · 2 generations on · 1 of its ownK203393 Fast-Fix FlexSmith & Nephew, Inc. · 2021
Descendant · 2 generations on · 1 of its ownK153667 TRUESPAN Meniscal Repair SystemMedos International SARL · 2016

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2005high 2 (2016) · low 0 (2006)2026

Most influential descendants

Showing 5 of 16 · See all

K121861Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB…Smith & Nephew, Inc. · 2012 · cites it directly12descendants
K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2019 · 2 generations on2descendants
K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2022 · 3 generations on1descendant
K203393Fast-Fix FlexSmith & Nephew, Inc. · 2021 · 2 generations on1descendant
K153667TRUESPAN Meniscal Repair SystemMedos International SARL · 2016 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K033654	Force Fiber	Teleflex Medical	2004	—
0 (this device)	K041216	Smith & Nephew Ultrabraid Suture	Smith & Nephew, Inc.	2004	—
+1	K121861	Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra…	Smith & Nephew, Inc.	2012	—
+2	K190125	FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire…	T.A.G. Medical Products Corporation, Ltd.	2019	—
+3	K221731	FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire…	T.A.G. Medical Products Corporation, Ltd.	2022	—
+2	K203393	Fast-Fix Flex	Smith & Nephew, Inc.	2021	—
+2	K153667	TRUESPAN Meniscal Repair System	Medos International SARL	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2011	1	0
2012	1	0
2013	1	0
2015	1	0
2016	2	0
2017	1	0
2019	1	0
2021	1	0
2022	1	0
2023	2	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K041216, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GAT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GAT device

#1 K230311 HyperSuturescore 20.2 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K033654	Force Fiber Summary page 1 …Co- Polyethylene Nonabsorbable Surgical Suture. K033654 and Teleflex Medical, Force Fiberi-T Blue Braid Polyethylene Nonabsorbable Surgical Suture, K040472.…	Teleflex Medical	2004	—
*	K040472	Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical Suture Summary page 1 …Polyethylene Nonabsorbable Surgical Suture. K033654 and Teleflex Medical, Force Fiberi-T Blue Braid Polyethylene Nonabsorbable Surgical Suture, K040472. E. Description of Device The Smith & NephewrM ULTRABRAIDrM Suture is a nonabsorbable, ste…	Teleflex Medical	2004	—

Also cleared against K033654: 6 other devices →

What descends from it? (16)

See all 16

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K121861	Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB…	Smith & Nephew, Inc.	2012	12
K101377	Smith & Newphew Ultrabraid II Suture	Smith & Newphew, Inc.	2011	1
K132357	Smith & Nephew Ultratape	Smith & Nephew, Inc.	2013	0
K051488	Medicinelodge Zipknot	Medicinelodge, Inc.	2005	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K121861 (Smith & Nephew, Inc., 2012) has gone furthest, with 12 descendants of its own.
6 other devices also cite its predicate K033654.

How does its category compare?

All GAT devices

GAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAT

5in 2025

2007high 11 (2010) · low 1 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAT

30in 2025

2007high 220 (2023) · low 27 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GAT

1in 2011

2007high 3 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAT

2,956in 2025

2007high 2,956 (2025) · low 15 (2007)2025

MAUDE reports naming product code GAT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	40	1	15
2008	4	93	0	15
2009	9	57	0	55
2010	11	27	3	79
2011	1	—	1	97
2012	6	61	0	253
2013	4	123	0	210
2014	4	45	0	165
2015	7	125	0	626
2016	10	139	0	688
2017	6	57	0	1,104
2018	6	95	0	1,453
2019	4	79	0	1,251
2020	5	201	0	1,220
2021	4	92	0	1,643
2022	5	109	0	1,419
2023	8	220	0	2,038
2024	3	140	0	2,597
2025	5	30	0	2,956
2026	5	83	0	—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041216 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041216: Smith & Nephew Ultrabraid Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041216

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026