510(k) · Cleared

Cleared

Force Fiber Suture

K191268510(k) SpecialCleared Jun 11, 201929-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

Teleflex Medical Incorporated · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Jun 11, 2019 as substantially equivalent to K033654 (Teleflex Medical, 2004) and 5 other predicates after a 29-day review. Its family tree reaches back 7 generations to 1999. 2 later devices descend from it.

Decided: Jun 11, 2019
Review: 29 days
Class: Class II
Product code: GAT
Recalls: None
Predicates: 6

Its longest line of descent runs back 7 generations to K990088 (1999). 37 ancestors in all, the oldest K885018 (1989). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 7 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
6 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
5 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
4 generations backK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
3 generations backK092533 Force Fiber Blue Ultra High Molecular Weight Polyethylene Non…Beere Precision Medical Instruments, Kmedic, Telef · 2009
2 generations backK150438 Force Fiber OrthoTape sutureTeleflexmedical, Inc. · 2015
1 generation backK181774 Force Fiber White and White/Blue, White/Black, Blue, and White/Green…Teleflex Medical Incorporated · 2018
This deviceK191268 Force Fiber SutureTeleflex Medical Incorporated · 2019
Descendant · cites it directly · 1 of its ownK210675 EasyWhipWinter Innovations, Inc. · 2021
Descendant · 2 generations on · 0 of its ownK261021 EasyWhip FamilyWinter Innovations, Inc. · 2026

Most influential descendants

Showing 2 of 2 · See all

K210675EasyWhipWinter Innovations, Inc. · 2021 · cites it directly1descendant
K261021EasyWhip FamilyWinter Innovations, Inc. · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K990088	Synthofil Nonabsorbable Pet Surgical Suture	Aesculap, Inc.	1999	—
−6	K012923	Arthrex Fiberwire, Usp Size 5, Model AR-7201	Arthrex, Inc.	2001	—
−5	K021434	Arthrex Fiberwire in Usp Sizes	Arthrex, Inc.	2002	—
−4	K063778	Force Fiber Polyethylene Nonabsorbable Suture	Teleflex Medical	2007	1
−3	K092533	Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures	Beere Precision Medical Instruments, Kmedic, Telef	2009	—
−2	K150438	Force Fiber OrthoTape suture	Teleflexmedical, Inc.	2015	—
−1	K181774	Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures…	Teleflex Medical Incorporated	2018	—
0 (this device)	K191268	Force Fiber Suture	Teleflex Medical Incorporated	2019	—
+1	K210675	EasyWhip	Winter Innovations, Inc.	2021	—
+2	K261021	EasyWhip Family	Winter Innovations, Inc.	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1990	1	0
1991	1	0
1992	1	0
1994	1	0
1995	3	0
1996	1	0
1997	2	0
1999	2	0
2000	4	0
2001	4	0
2002	1	0
2003	2	0
2004	3	0
2005	1	0
2007	1	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0
2026	1	0

FIG. 1 — Lineage of K191268, 1999–2026Source: 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

Get a 510(k) Report

What was it cleared against? (6)

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 5 …Fiber Suture - Black is substantially equivalent in intended use and fundamental scientific technology to the Force Fiber Suture predicate devices cleared under 510(k) #K033654 on 1/15/2004, K063778 on 2/09/2007, K070673 on 4/2/2007, K092533 on 9/15/2009, K100506 on 3/10/2010 and K181774 on 10/10/2018. T…	Teleflex Medical	2004	—
*	K063778	Force Fiber Polyethylene Nonabsorbable Suture Summary page 5 …is substantially equivalent in intended use and fundamental scientific technology to the Force Fiber Suture predicate devices cleared under 510(k) #K033654 on 1/15/2004, K063778 on 2/09/2007, K070673 on 4/2/2007, K092533 on 9/15/2009, K100506 on 3/10/2010 and K181774 on 10/10/2018. Technological Character…	Teleflex Medical	2007	1
*	K070673	Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture Summary page 5 …alent in intended use and fundamental scientific technology to the Force Fiber Suture predicate devices cleared under 510(k) #K033654 on 1/15/2004, K063778 on 2/09/2007, K070673 on 4/2/2007, K092533 on 9/15/2009, K100506 on 3/10/2010 and K181774 on 10/10/2018. Technological Characteristics Force Fiber Sut…	Teleflexmedical, Inc.	2007	—
*	K092533	Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures Summary page 5 …and fundamental scientific technology to the Force Fiber Suture predicate devices cleared under 510(k) #K033654 on 1/15/2004, K063778 on 2/09/2007, K070673 on 4/2/2007, K092533 on 9/15/2009, K100506 on 3/10/2010 and K181774 on 10/10/2018. Technological Characteristics Force Fiber Suture – Black is substa…	Beere Precision Medical Instruments, Kmedic, Telef	2009	—
*	K100506	Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures… Summary page 5 …tific technology to the Force Fiber Suture predicate devices cleared under 510(k) #K033654 on 1/15/2004, K063778 on 2/09/2007, K070673 on 4/2/2007, K092533 on 9/15/2009, K100506 on 3/10/2010 and K181774 on 10/10/2018. Technological Characteristics Force Fiber Suture – Black is substantially equivalent to…	Teleflex Medical	2010	—
*	K181774	Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force… Summary page 5 …orce Fiber Suture predicate devices cleared under 510(k) #K033654 on 1/15/2004, K063778 on 2/09/2007, K070673 on 4/2/2007, K092533 on 9/15/2009, K100506 on 3/10/2010 and K181774 on 10/10/2018. Technological Characteristics Force Fiber Suture – Black is substantially equivalent to its predicate Force Fiber…	Teleflex Medical Incorporated	2018	—

Also cleared against K033654: 6 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K210675	EasyWhip	Winter Innovations, Inc.	2021	1

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?

The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
15 of the 37 ancestors have a recall of any class.
Of its descendants, K210675 (Winter Innovations, Inc., 2021) has gone furthest, with 1 descendant 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. 2019, this device’s year, is highlighted.

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?

Force Fiber® Non-absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues,

including use in cardiovascular surgeries and the use of allograft tissue for orthopedic surgeries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K191268 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191268: Force Fiber Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191268

Report an extraction error

Are you the manufacturer?

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