510(k) Report

510(k) · Cleared

Cleared

Arthrex Fiberwire in Usp Sizes

K021434510(k) TraditionalCleared Nov 7, 2002185-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

Arthrex, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Nov 7, 2002 as substantially equivalent to K010673 (Arthrex, Inc., 2001) and 4 other predicates after a 185-day review. Its family tree reaches back 2 generations to 1999. 259 later devices descend from it.

Decided
Nov 7, 2002
Review
185 days
Class
Class II
Product code
GAT
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K990088 (1999). 7 ancestors in all. 259 later devices descend from it, 11 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2000: 3 other ancestors2018: 10 descendants cleared2004: 4 descendants cleared2007: 5 descendants cleared2009: 8 descendants cleared2010: 4 descendants cleared2008: 2 descendants cleared2003: 1 descendant cleared2006: 1 descendant cleared2005: 2 descendants cleared2012: 6 descendants cleared2015: 17 descendants cleared2019: 19 descendants cleared2023: 24 descendants cleared2013: 9 descendants cleared2021: 18 descendants cleared2014: 15 descendants cleared2017: 10 descendants cleared2025: 20 descendants cleared2011: 3 descendants cleared2020: 16 descendants cleared2024: 24 descendants cleared2016: 9 descendants cleared2022: 12 descendants cleared2026: 20 descendants clearedK990088 · Synthofil Nonabsorbable Pet Surgical Suture · Aesculap, Inc. · 1999K012923 · Arthrex Fiberwire, Usp Size 5, Model AR-7201 · Arthrex, Inc. · 20011995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor 1 generation forward: 11 descendants2 generations forward: 36 descendants3 generations forward: 57 descendants4 generations forward: 49 descendants5 generations forward: 52 descendants6 generations forward: 25 descendants7 generations forward: 20 descendants8 generations forward: 8 descendants9 generations forward: 1 descendant K012923 · Arthrex Fiberwire, Usp Size 5, Model AR-7201 · Arthrex, Inc. · 2001K990088 · Synthofil Nonabsorbable Pet Surgical Suture · Aesculap, Inc. · 19990+5
  1. Root · 2 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
  2. 1 generation backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
  3. This deviceK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
  4. Descendant · cites it directly · 161 of its ownK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
  5. Descendant · 2 generations on · 143 of its ownK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
  6. Descendant · cites it directly · 69 of its ownK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
  7. Descendant · 2 generations on · 65 of its ownK100652 Acl TightropeArthrex, Inc. · 2010
  8. Descendant · 2 generations on · 52 of its ownK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012

Showing 5 of 259 descendants. See all descendants

Descendants cleared per year

2003: 12004: 42005: 22006: 12007: 52008: 22009: 82010: 42011: 32012: 62013: 92014: 152015: 172016: 92017: 102018: 102019: 192020: 162021: 182022: 122023: 242024: 242025: 202026: 20
2003high 24 (2023) · low 1 (2003)2026

Most influential descendants

Showing 5 of 259 · See all
  • K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · cites it directly161descendants
  • K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006 · 2 generations on143descendants
  • K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · cites it directly69descendants
  • K100652Acl TightropeArthrex, Inc. · 2010 · 2 generations on65descendants
  • K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc. · 2012 · 2 generations on52descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K990088Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc.1999—
−1K012923Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc.2001—
0 (this device)K021434Arthrex Fiberwire in Usp SizesArthrex, Inc.2002—
+1K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031
+2K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006—
+1K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical20071
+2K100652Acl TightropeArthrex, Inc.2010—
+2K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button…Arthrex, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200030
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200440
200520
200610
200750
200820
200980
201040
201130
201260
201390
2014150
2015170
201690
2017100
2018100
2019190
2020160
2021180
2022120
2023240
2024240
2025200
2026200
FIG. 1 — Lineage of K021434, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K010673Arthrex Fiberwire, Model Spu-02NB-3800Arthrex, Inc.2001—
*K012923Arthrex Fiberwire, Usp Size 5, Model AR-7201
Summary page 1
…: Suture, Non-absorbable, Synthetic, Polyester Predicate Devices : Arthrex KO10673, Arthrex KO12923, Grams American Suture KO03590 Arthrex K012923, ARC Medical Supplies K000540, Genzyme Surgical Product KO01434. This summary of…
Arthrex, Inc.2001—
*K003590Grams Polyester Nonabsorbable SutureGramsmed, LLC2001—
*K000540Polyester Nonabsorbable Surgical Sutures, Usp
Summary page 1
…icate Devices : Arthrex KO10673, Arthrex KO12923, Grams American Suture KO03590 Arthrex K012923, ARC Medical Supplies K000540, Genzyme Surgical Product KO01434. This summary of 51O(k) safety and effectiveness information is being…
Arc Medical Supplies (Beijing) Co, Ltd.2000—
*K001434'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery)20001

Also cleared against K010673: 7 other devices →

What descends from it? (259)

See all 259

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

NumberDeviceApplicantDecidedDescendants
K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.2003161
K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical200769
K032245Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM…Arthrex, Inc.200437
K041553Arthrex Suture Grafting KitArthrex, Inc.200431
K083792Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055Medshape Solutions20094
K041894OrthofiberCp Medical20044
K041589Arthrex Fiberwire with SilkArthrex, Inc.20044
K091202Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures,Model 1000-01 Tab Varying…Medshape Solutions20093
K181182DYNACORD SutureMedos International SARL20181
K094028CP-Fiber (Orthofiber)Cp Medical20100

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 3 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K031666 (Arthrex, Inc., 2003) has gone furthest, with 161 descendants of its own.
  • 7 other devices also cite its predicate K010673.

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?

FiberwireTMUSP sizes are intended for use in approximation or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.

Indications for use as stated in the FDA summary.

Also cleared against K010673

7 other devices cite the same predicate.

  • K041553Arthrex Suture Grafting KitArthrex, Inc. · 2004
  • K041894OrthofiberCp Medical · 2004
  • K040004Orthocord SutureDepuy Mitek · 20041 recall
  • K033718Maxbraid Polyester Plus and Polyethylene Plus SutureArthrotek, Inc. · 2004
  • K032245Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM, Models AR-7237…Arthrex, Inc. · 2004
  • K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 20031 recall

More from Arthrex, Inc.

355 FDA decisions under this applicant name. See the company

  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260624Arthrex Radial Head Replacement SystemArthrex, Inc. · 2026

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/K021434 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021434: Arthrex Fiberwire in Usp Sizes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021434

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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