510(k) Report

510(k) · Cleared

Recalled · 2007

'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture

K001434510(k) TraditionalCleared Jun 12, 200035-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

Genzyme Surgical Product (Genzyme Biosurgery) · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Jun 12, 2000 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 274 later devices descend from it. It has been recalled once.

Decided
Jun 12, 2000
Review
35 days
Class
Class II
Product code
GAT
Recalls
1
Predicates
0

274 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2009: 9 descendants cleared2023: 27 descendants cleared2004: 4 descendants cleared2007: 5 descendants cleared2006: 3 descendants cleared2001: 1 descendant cleared2003: 1 descendant cleared2018: 12 descendants cleared2010: 4 descendants cleared2008: 3 descendants cleared2019: 19 descendants cleared2012: 6 descendants cleared2013: 9 descendants cleared2021: 18 descendants cleared2005: 2 descendants cleared2015: 17 descendants cleared2014: 15 descendants cleared2017: 11 descendants cleared2025: 20 descendants cleared2022: 13 descendants cleared2016: 9 descendants cleared2026: 20 descendants cleared2011: 3 descendants cleared2020: 16 descendants cleared2024: 26 descendants cleared200020052010201520202025
  1. This deviceK001434 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester…Genzyme Surgical Product (Genzyme Biosurgery) · 2000
  2. Descendant · cites it directly · 260 of its ownK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
  3. Descendant · cites it directly · 259 of its ownK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
  4. Descendant · 2 generations on · 161 of its ownK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
  5. Descendant · 3 generations on · 143 of its ownK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
  6. Descendant · 2 generations on · 69 of its ownK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled

Showing 5 of 274 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12003: 12004: 42005: 22006: 32007: 52008: 32009: 92010: 42011: 32012: 62013: 92014: 152015: 172016: 92017: 112018: 122019: 192020: 162021: 182022: 132023: 272024: 262025: 202026: 20
2001high 27 (2023) · low 1 (2001)2026

Most influential descendants

Showing 5 of 274 · See all
  • K012923Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001 · cites it directly260descendants
  • K021434Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002 · cites it directly259descendants
  • K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · 2 generations on161descendants
  • K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006 · 3 generations on143descendants
  • K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · 2 generations on69descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001434'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable…Genzyme Surgical Product (Genzyme Biosurgery)2000—
+1K012923Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc.2001—
+1K021434Arthrex Fiberwire in Usp SizesArthrex, Inc.2002—
+2K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031
+3K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006—
+2K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical20071

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200310
200440
200520
200630
200750
200830
200990
201040
201130
201260
201390
2014150
2015170
201690
2017110
2018120
2019190
2020160
2021180
2022130
2023270
2024260
2025200
2026200
FIG. 1 — Lineage of K001434, 2000–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (274)

See all 274

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

NumberDeviceApplicantDecidedDescendants
K012923Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc.2001260
K021434Arthrex Fiberwire in Usp SizesArthrex, Inc.2002259
K041553Arthrex Suture Grafting KitArthrex, Inc.200431
K060165Axyaflex Polyester SutureAxya Medical, Inc.200611
K091061Implicitguide Surgical Suture SystemImplicitcare, LLC20091
K230510MyEllevateCynosure, LLC20230
K071796Capsew Plication SystemCayenne Medical, Inc.20070

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 6, 2007Not classifiedZ-1017-2007OtherSuture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K012923 (Arthrex, Inc., 2001) has gone furthest, with 260 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—

More from Genzyme Surgical Product (Genzyme…

9 FDA decisions under this applicant name. See the company

  • K001440Nextstitch Cardiovascular Valve SutureGenzyme Surgical Product (Genzyme Biosurgery) · 20001 recall
  • K992088Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery) · 19996 recalls
  • K991416Endoscopic CameraGenzyme Surgical Product (Genzyme Biosurgery) · 1999
  • K991191Bondek Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery) · 19991 recall
  • K990062SaphliftGenzyme Surgical Product (Genzyme Biosurgery) · 1999

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/K001434 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001434: 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001434

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026