510(k) · Cleared

Cleared

Force Fiber Fusion Suture

K172016510(k) TraditionalCleared Oct 3, 201792-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 Oct 3, 2017 as substantially equivalent to K150438 (Teleflexmedical, Inc., 2015) and 4 other predicates after a 92-day review. Its family tree reaches back 6 generations to 1999. 1 later device descends from it.

Decided: Oct 3, 2017
Review: 92 days
Class: Class II
Product code: GAT
Recalls: None
Predicates: 5

Its longest line of descent runs back 6 generations to K990088 (1999). 19 ancestors in all, the oldest K930738 (1994). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 6 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
5 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
4 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
3 generations backK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
2 generations backK092533 Force Fiber Blue Ultra High Molecular Weight Polyethylene Non…Beere Precision Medical Instruments, Kmedic, Telef · 2009
1 generation backK150438 Force Fiber OrthoTape sutureTeleflexmedical, Inc. · 2015
This deviceK172016 Force Fiber Fusion SutureTeleflex Medical Incorporated · 2017
Descendant · cites it directly · 0 of its ownK260775 Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC · 2026

Most influential descendants

Showing 1 of 1 · See all

K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K990088	Synthofil Nonabsorbable Pet Surgical Suture	Aesculap, Inc.	1999	—
−5	K012923	Arthrex Fiberwire, Usp Size 5, Model AR-7201	Arthrex, Inc.	2001	—
−4	K021434	Arthrex Fiberwire in Usp Sizes	Arthrex, Inc.	2002	—
−3	K063778	Force Fiber Polyethylene Nonabsorbable Suture	Teleflex Medical	2007	1
−2	K092533	Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures	Beere Precision Medical Instruments, Kmedic, Telef	2009	—
−1	K150438	Force Fiber OrthoTape suture	Teleflexmedical, Inc.	2015	—
0 (this device)	K172016	Force Fiber Fusion Suture	Teleflex Medical Incorporated	2017	—
+1	K260775	Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™	Teleflex Medical, LLC	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1996	1	0
2000	3	0
2001	3	0
2004	2	0
2005	1	0
2007	1	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K172016, 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? (5)

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
*	K150438	Force Fiber OrthoTape suture Summary page 5 …Fiber Fusion suture is substantially equivalent in intended use and fundamental scientific technology to its primary predicate Force Fiber OrthoTape suture cleared under K150438 on 04/02/2015. The other listed predicates are part of the same Force Fiber suture family cleared under 510(k)s K063778 on 2/09/2…	Teleflexmedical, Inc.	2015	—
*	K063778	Force Fiber Polyethylene Nonabsorbable Suture Summary page 5 …dicate Force Fiber OrthoTape suture cleared under K150438 on 04/02/2015. The other listed predicates are part of the same Force Fiber suture family cleared under 510(k)s K063778 on 2/09/2007, K070673 on 4/2/2007, K092533 on 9/15/2009, and K100506 on 3/10/2010. Technological Characteristics Force Fiber Fus…	Teleflex Medical	2007	1
*	K070673	Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture Summary page 5 …hoTape suture cleared under K150438 on 04/02/2015. The other listed predicates are part of the same Force Fiber suture family cleared under 510(k)s K063778 on 2/09/2007, K070673 on 4/2/2007, K092533 on 9/15/2009, and K100506 on 3/10/2010. Technological Characteristics Force Fiber Fusion suture is substant…	Teleflexmedical, Inc.	2007	—
*	K092533	Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures Summary page 5 …under K150438 on 04/02/2015. The other listed predicates are part of the same Force Fiber suture family cleared under 510(k)s K063778 on 2/09/2007, K070673 on 4/2/2007, K092533 on 9/15/2009, and K100506 on 3/10/2010. Technological Characteristics Force Fiber Fusion suture is substantially equivalent to i…	Beere Precision Medical Instruments, Kmedic, Telef	2009	—
*	K100506	Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures… Summary page 5 …15. The other listed predicates are part of the same Force Fiber suture family cleared under 510(k)s K063778 on 2/09/2007, K070673 on 4/2/2007, K092533 on 9/15/2009, and K100506 on 3/10/2010. Technological Characteristics Force Fiber Fusion suture is substantially equivalent to its predicate device Force…	Teleflex Medical	2010	—

Also cleared against K150438: 3 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K260775	Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™	Teleflex Medical, LLC	2026	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?

The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
6 of the 19 ancestors have a recall of any class.
Of its descendants, K260775 (Teleflex Medical, LLC, 2026) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K150438.

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. 2017, 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 Fusion™ Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopaedic surgeries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K172016 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172016: Force Fiber Fusion Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172016

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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