510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Force Fiber Polyethylene Nonabsorbable Suture

K063778510(k) AbbreviatedCleared Feb 9, 200750-day reviewClass II21 CFR 878.5000Recalls 1

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 Feb 9, 2007 as substantially equivalent to K033654 (Teleflex Medical, 2004) and 3 other predicates after a 50-day review. Its family tree reaches back 3 generations to 1999. 69 later devices descend from it. It has been recalled once.

Decided
Feb 9, 2007
Review
50 days
Class
Class II
Product code
GAT
Recalls
1
Predicates
4

Its longest line of descent runs back 3 generations to K990088 (1999). 13 ancestors in all, the oldest K954808 (1996). 69 later devices descend from it, 17 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2004: 2 other ancestors2001: 3 other ancestors2000: 3 other ancestors1996: 1 other ancestor2009: 3 descendants cleared2018: 5 descendants cleared2015: 10 descendants cleared2010: 3 descendants cleared2019: 4 descendants cleared2014: 3 descendants cleared2017: 4 descendants cleared2013: 4 descendants cleared2007: 2 descendants cleared2012: 3 descendants cleared2020: 3 descendants cleared2024: 6 descendants cleared2016: 3 descendants cleared2021: 2 descendants cleared2026: 6 descendants cleared2023: 4 descendants cleared2025: 4 descendants clearedK990088 · Synthofil Nonabsorbable Pet Surgical Suture · Aesculap, Inc. · 1999K012923 · Arthrex Fiberwire, Usp Size 5, Model AR-7201 · Arthrex, Inc. · 2001K021434 · Arthrex Fiberwire in Usp Sizes · Arthrex, Inc. · 20021995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 6 other ancestors3 generations back: 1 other ancestor 1 generation forward: 17 descendants2 generations forward: 24 descendants3 generations forward: 14 descendants4 generations forward: 6 descendants5 generations forward: 5 descendants6 generations forward: 3 descendants K021434 · Arthrex Fiberwire in Usp Sizes · Arthrex, Inc. · 2002K012923 · Arthrex Fiberwire, Usp Size 5, Model AR-7201 · Arthrex, Inc. · 2001K990088 · Synthofil Nonabsorbable Pet Surgical Suture · Aesculap, Inc. · 19990+5
  1. Root · 3 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
  2. 2 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
  3. 1 generation backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
  4. This deviceK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007
  5. Descendant · cites it directly · 29 of its ownK092533 Force Fiber Blue Ultra High Molecular Weight Polyethylene Non…Beere Precision Medical Instruments, Kmedic, Telef · 2009
  6. Descendant · cites it directly · 23 of its ownK070673 Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc. · 2007
  7. Descendant · cites it directly · 15 of its ownK100006 HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro…Riverpoint Medical · 2010 · Recalled
  8. Descendant · cites it directly · 14 of its ownK150438 Force Fiber OrthoTape sutureTeleflexmedical, Inc. · 2015
  9. Descendant · cites it directly · 10 of its ownK181774 Force Fiber White and White/Blue, White/Black, Blue, and White/Green…Teleflex Medical Incorporated · 2018

Showing 5 of 69 descendants. See all descendants

Descendants cleared per year

2007: 22009: 32010: 32012: 32013: 42014: 32015: 102016: 32017: 42018: 52019: 42020: 32021: 22023: 42024: 62025: 42026: 6
2007high 10 (2015) · low 0 (2008)2026

Most influential descendants

Showing 5 of 69 · See all
  • K092533Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable SuturesBeere Precision Medical Instruments, Kmedic, Telef · 2009 · cites it directly29descendants
  • K070673Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc. · 2007 · cites it directly23descendants
  • K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…Riverpoint Medical · 2010 · cites it directly15descendants
  • K150438Force Fiber OrthoTape sutureTeleflexmedical, Inc. · 2015 · cites it directly14descendants
  • K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated · 2018 · cites it directly10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K990088Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc.1999—
−2K012923Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc.2001—
−1K021434Arthrex Fiberwire in Usp SizesArthrex, Inc.2002—
0 (this device)K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical2007—
+1K092533Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable SuturesBeere Precision Medical Instruments, Kmedic, Telef2009—
+1K070673Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc.2007—
+1K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene)…Riverpoint Medical20102
+1K150438Force Fiber OrthoTape sutureTeleflexmedical, Inc.2015—
+1K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures…Teleflex Medical Incorporated2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200030
200130
200420
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200930
201030
201230
201340
201430
2015100
201630
201740
201850
201940
202030
202120
202340
202460
202540
202660
FIG. 1 — Lineage of K063778, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (4)

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
*K033654Force Fiber
Summary page 1
…e is similar in intended use, materials, design, and performance characteristics to the Teleflex Medical Force Fiber® Polyethylene Non-absorbable Surgical Sutures (K033654, K040472), the United States Surgical Surgipro I! Non-Absorbable Surgical Sutures (K050947) and the Arthrex Fiberwire Polyethy…
Teleflex Medical2004—
*K040472Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical Suture
Summary page 1
…lar in intended use, materials, design, and performance characteristics to the Teleflex Medical Force Fiber® Polyethylene Non-absorbable Surgical Sutures (K033654, K040472), the United States Surgical Surgipro I! Non-Absorbable Surgical Sutures (K050947) and the Arthrex Fiberwire Polyethylene Non-…
Teleflex Medical2004—
*K050947Modification to: Modified Uss Polypropylene Suture
Summary page 1
…eflex Medical Force Fiber® Polyethylene Non-absorbable Surgical Sutures (K033654, K040472), the United States Surgical Surgipro I! Non-Absorbable Surgical Sutures (K050947) and the Arthrex Fiberwire Polyethylene Non-absorbable Surgical Sutures 15 ===…
United States Surgical, A Division of Tyco Healthc20052
*K021434Arthrex Fiberwire in Usp Sizes
Summary page 2
…15 Teleflex Medical Force Fiber® Non-Absorbable Surgical Suture Abbreviated PreMarket Notification (510(k)) Submission (K021434). The determination of substantial equivalence for this device was based on a detailed device description, performance testin…
Arthrex, Inc.2002—

Also cleared against K033654: 6 other devices →

What descends from it? (69)

See all 69

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

NumberDeviceApplicantDecidedDescendants
K092533Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable SuturesBeere Precision Medical Instruments, Kmedic, Telef200929
K070673Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc.200723
K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…Riverpoint Medical201015
K150438Force Fiber OrthoTape sutureTeleflexmedical, Inc.201514
K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated201810
K122336Q-Fix Suture Anchor, 1.8MM Q-Fix Access Tools (Drill Guide W/Obturator, Drill Bit) 1.8MMEleven Blade Solutions, Inc.20137
K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143
K191268Force Fiber SutureTeleflex Medical Incorporated20192
K143356NovoStitch Plus Meniscal Repair SystemCeterix Orthopaedics, Inc.20152
K090530Spin-Loc Suture Anchor System FG-0302-01,FG-0305-01Ross Creek Medical, Inc.20092

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 11, 2014Class IIZ-1559-2014Employee errorProduct does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
  • 4 of the 13 ancestors have a recall of any class.
  • Of its descendants, K092533 (Beere Precision Medical Instruments, Kmedic, Telef, 2009) has gone furthest, with 29 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. 2007, this device’s year, is highlighted.

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® Polyethylene 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 orthopaedic surgeries.

Indications for use as stated in the FDA summary.

Also cleared against K033654

6 other devices cite the same predicate.

  • K191268Force Fiber SutureTeleflex Medical Incorporated · 2019
  • K151009Nexus SutureBaylis Medical Company, Inc. · 2015
  • K150584Stryker Suture TapeStryker · 2015
  • K150438Force Fiber OrthoTape sutureTeleflexmedical, Inc. · 2015
  • K071375Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)Disc-O-Tech Medical Technologies, Ltd. · 2007
  • K041216Smith & Nephew Ultrabraid SutureSmith & Nephew, Inc. · 2004

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/K063778 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063778: Force Fiber Polyethylene Nonabsorbable Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063778

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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