510(k) Report

510(k) · Cleared

Cleared

Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures

K092533510(k) SpecialCleared Sep 15, 200927-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

Beere Precision Medical Instruments, Kmedic, Telef · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Sep 15, 2009 as substantially equivalent to K063778 (Teleflex Medical, 2007) after a 27-day review. Its family tree reaches back 4 generations to 1999. 29 later devices descend from it.

Decided
Sep 15, 2009
Review
27 days
Class
Class II
Product code
GAT
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K990088 (1999). 14 ancestors in all, the oldest K954808 (1996). 29 later devices descend from it, 10 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 ancestor2018: 1 descendant cleared2015: 3 descendants cleared2012: 2 descendants cleared2019: 3 descendants cleared2017: 3 descendants cleared2013: 2 descendants cleared2016: 2 descendants cleared2026: 4 descendants cleared2023: 2 descendants cleared2021: 1 descendant cleared2025: 2 descendants cleared2024: 3 descendants cleared2020: 1 descendant 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. · 2002K063778 · Force Fiber Polyethylene Nonabsorbable Suture · Teleflex Medical · 2007 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 6 other ancestors4 generations back: 1 other ancestor 1 generation forward: 10 descendants2 generations forward: 8 descendants3 generations forward: 7 descendants4 generations forward: 1 descendant5 generations forward: 3 descendants K063778 · Force Fiber Polyethylene Nonabsorbable Suture · Teleflex Medical · 2007 · recalledK021434 · 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 · 4 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
  2. 3 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
  3. 2 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
  4. 1 generation backK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
  5. This deviceK092533 Force Fiber Blue Ultra High Molecular Weight Polyethylene Non…Beere Precision Medical Instruments, Kmedic, Telef · 2009
  6. Descendant · cites it directly · 14 of its ownK150438 Force Fiber OrthoTape sutureTeleflexmedical, Inc. · 2015
  7. Descendant · cites it directly · 10 of its ownK181774 Force Fiber White and White/Blue, White/Black, Blue, and White/Green…Teleflex Medical Incorporated · 2018
  8. Descendant · cites it directly · 7 of its ownK132867 Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture…Cayenne Medical, Inc. · 2013
  9. Descendant · 2 generations on · 6 of its ownK151068 SureLock W Suture AnchorCayenne Medical, Inc. · 2015
  10. Descendant · 2 generations on · 4 of its ownK230311 HyperSutureThreadstone, LLC · 2023

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2012: 22013: 22015: 32016: 22017: 32018: 12019: 32020: 12021: 12023: 22024: 32025: 22026: 4
2012high 4 (2026) · low 0 (2014)2026

Most influential descendants

Showing 5 of 29 · See all
  • 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
  • K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc. · 2013 · cites it directly7descendants
  • K151068SureLock W Suture AnchorCayenne Medical, Inc. · 2015 · 2 generations on6descendants
  • K230311HyperSutureThreadstone, LLC · 2023 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K990088Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc.1999—
−3K012923Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc.2001—
−2K021434Arthrex Fiberwire in Usp SizesArthrex, Inc.2002—
−1K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical20071
0 (this device)K092533Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable SuturesBeere Precision Medical Instruments, Kmedic, Telef2009—
+1K150438Force Fiber OrthoTape sutureTeleflexmedical, Inc.2015—
+1K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures…Teleflex Medical Incorporated2018—
+1K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor…Cayenne Medical, Inc.2013—
+2K151068SureLock W Suture AnchorCayenne Medical, Inc.2015—
+2K230311HyperSutureThreadstone, LLC2023—

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
201220
201320
201530
201620
201730
201810
201930
202010
202110
202320
202430
202520
202640
FIG. 1 — Lineage of K092533, 1999–2026Source: 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
*K063778Force Fiber Polyethylene Nonabsorbable Suture
Summary page 2
…ion The device has the same intended use and fundamental scientific technology as Teleflex Medical Force Fiber® Polyethylene Non-absorbable Surgical Suture (K063 778). The determination of substantial equivalence for this device was based on a detailed device description, performance…
Teleflex Medical20071

Also cleared against K063778: 16 other devices →

What descends from it? (29)

See all 29

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

NumberDeviceApplicantDecidedDescendants
K150438Force Fiber OrthoTape sutureTeleflexmedical, Inc.201514
K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated201810
K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137
K191268Force Fiber SutureTeleflex Medical Incorporated20192
K150584Stryker Suture TapeStryker20152
K172016Force Fiber Fusion SutureTeleflex Medical Incorporated20171
K112960Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe…Cayenne Medical, Inc.20121
K170642GRAVITY™ Soft Tissue Repair SystemWrightmedicaltechnologyinc20170
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?

  • The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
  • 5 of the 14 ancestors have a recall of any class.
  • Of its descendants, K150438 (Teleflexmedical, Inc., 2015) has gone furthest, with 14 descendants of its own.
  • 16 other devices also cite its predicate K063778.

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. 2009, 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 K063778

16 other devices cite the same predicate.

  • K191268Force Fiber SutureTeleflex Medical Incorporated · 2019
  • K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture…Teleflex Medical Incorporated · 2018
  • K172016Force Fiber Fusion SutureTeleflex Medical Incorporated · 2017
  • K170642GRAVITY™ Soft Tissue Repair SystemWrightmedicaltechnologyinc · 2017
  • K143356NovoStitch Plus Meniscal Repair SystemCeterix Orthopaedics, Inc. · 2015
  • K150327Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2Dunamis, LLC · 2015

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/K092533 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092533: Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092533

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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