510(k) Report

510(k) · Cleared

Cleared

Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical Suture

K040472510(k) SpecialCleared Mar 15, 200420-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 · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Mar 15, 2004 after a 20-day review. The FDA summary names its predicate without a number. 92 later devices descend from it.

Decided
Mar 15, 2004
Review
20 days
Class
Class II
Product code
GAT
Recalls
None
Predicates
0

92 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2015: 13 descendants cleared2004: 1 descendant cleared2012: 4 descendants cleared2007: 3 descendants cleared2013: 5 descendants cleared2006: 1 descendant cleared2005: 1 descendant cleared2011: 2 descendants cleared2019: 6 descendants cleared2009: 3 descendants cleared2018: 5 descendants cleared2010: 3 descendants cleared2014: 3 descendants cleared2017: 5 descendants cleared2020: 3 descendants cleared2024: 7 descendants cleared2016: 5 descendants cleared2021: 3 descendants cleared2023: 6 descendants cleared2025: 5 descendants cleared2026: 7 descendants cleared2022: 1 descendant cleared200020052010201520202025
  1. This deviceK040472 Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical SutureTeleflex Medical · 2004
  2. Descendant · cites it directly · 69 of its ownK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
  3. Descendant · 2 generations on · 29 of its ownK092533 Force Fiber Blue Ultra High Molecular Weight Polyethylene Non…Beere Precision Medical Instruments, Kmedic, Telef · 2009
  4. Descendant · 2 generations on · 23 of its ownK070673 Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc. · 2007
  5. Descendant · cites it directly · 16 of its ownK041216 Smith & Nephew Ultrabraid SutureSmith & Nephew, Inc. · 2004
  6. Descendant · 2 generations on · 15 of its ownK100006 HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro…Riverpoint Medical · 2010 · Recalled

Showing 5 of 92 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 12007: 32009: 32010: 32011: 22012: 42013: 52014: 32015: 132016: 52017: 52018: 52019: 62020: 32021: 32022: 12023: 62024: 72025: 52026: 7
2004high 13 (2015) · low 0 (2008)2026

Most influential descendants

Showing 5 of 92 · See all
  • K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · cites it directly69descendants
  • K092533Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable SuturesBeere Precision Medical Instruments, Kmedic, Telef · 2009 · 2 generations on29descendants
  • K070673Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc. · 2007 · 2 generations on23descendants
  • K041216Smith & Nephew Ultrabraid SutureSmith & Nephew, Inc. · 2004 · cites it directly16descendants
  • K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…Riverpoint Medical · 2010 · 2 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K040472Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical SutureTeleflex Medical2004—
+1K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical20071
+2K092533Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable SuturesBeere Precision Medical Instruments, Kmedic, Telef2009—
+2K070673Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc.2007—
+1K041216Smith & Nephew Ultrabraid SutureSmith & Nephew, Inc.2004—
+2K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene)…Riverpoint Medical20102

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200610
200730
200930
201030
201120
201240
201350
201430
2015130
201650
201750
201850
201960
202030
202130
202210
202360
202470
202550
202670
FIG. 1 — Lineage of K040472, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230311 HyperSuturescore 20.2 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Force Fiber Polyethylene Non-Absorbable Surgical Suture
Named without a submission number
—

What descends from it? (92)

See all 92

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

NumberDeviceApplicantDecidedDescendants
K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical200769
K041216Smith & Nephew Ultrabraid SutureSmith & Nephew, Inc.200416
K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137
K061776Arthrotek Maxfire Meniscal Repair DeviceArthrotek, Inc.20066
K112960Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe…Cayenne Medical, Inc.20121
K151009Nexus SutureBaylis Medical Company, Inc.20150
K131325Quattro GL Suture AnchorCayenne Medical, Inc.20130
K112814CuffinkCayenne Medical, Inc.20120

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?

  • Of its descendants, K063778 (Teleflex Medical, 2007) has gone furthest, with 69 descendants of its own.

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

2007: 62008: 42009: 92010: 112011: 12012: 62013: 42014: 42015: 72016: 102017: 62018: 62019: 42020: 52021: 42022: 52023: 82024: 32025: 52026 (partial year): 5
2007high 11 (2010) · low 1 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAT

30in 2025

2007: 40 days median2008: 93 days median2009: 57 days median2010: 27 days median2012: 61 days median2013: 123 days median2014: 45 days median2015: 125 days median2016: 139 days median2017: 57 days median2018: 95 days median2019: 79 days median2020: 201 days median2021: 92 days median2022: 109 days median2023: 220 days median2024: 140 days median2025: 30 days median2026 (partial year): 83 days median
2007high 220 (2023) · low 27 (2010)2026

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

Recalls per year · GAT

1in 2011

2007: 12010: 32011: 1
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

2007: 152008: 152009: 552010: 792011: 972012: 2532013: 2102014: 1652015: 6262016: 6882017: 1,1042018: 1,4532019: 1,2512020: 1,2202021: 1,6432022: 1,4192023: 2,0382024: 2,5972025: 2,956
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007640115
2008493015
2009957055
20101127379
20111—197
20126610253
201341230210
20144450165
201571250626
2016101390688
201765701,104
201869501,453
201947901,251
2020520101,220
202149201,643
2022510901,419
2023822002,038
2024314002,597
202553002,956
20265830—

What is it indicated for?

Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including the use of allograft tissue for orthopaedic surgeries.

Indications for use as stated in the FDA summary.

More from Teleflex Medical

40 FDA decisions under this applicant name. See the company

  • K261418Liquick X-treme, Liquick X-treme PlusTeleflex Medical · 2026
  • K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical · 2025
  • K242495LMA Fastrach ETT SUTeleflex Medical · 2025
  • K243553QuikClot Control+ Hemostatic DeviceTeleflex Medical · 2025
  • K241784Arrow® Nitinol WireTeleflex Medical · 2024

Recent decisions in GAT

The GAT category page

  • K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda. · 2026
  • K261021EasyWhip FamilyWinter Innovations, Inc. · 2026
  • K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC · 2026
  • K254275HyperSuture All Green Extension LineThreadstone, LLC · 2026
  • K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda. · 2026

https://510kreport.com/device/K040472 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040472: Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040472

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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