510(k) Report

510(k) · Cleared

Cleared

Grams Polyester Nonabsorbable Suture

K003590510(k) TraditionalCleared Mar 5, 2001104-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

Gramsmed, LLC · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Mar 5, 2001 after a 104-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 281 later devices descend from it.

Decided
Mar 5, 2001
Review
104 days
Class
Class II
Product code
GAT
Recalls
None
Predicates
0

281 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2004: 4 descendants cleared2003: 2 descendants cleared2001: 1 descendant cleared2018: 12 descendants cleared2007: 5 descendants cleared2009: 8 descendants cleared2010: 5 descendants cleared2008: 2 descendants cleared2019: 20 descendants cleared2023: 26 descendants cleared2012: 7 descendants cleared2013: 10 descendants cleared2021: 19 descendants cleared2006: 1 descendant cleared2005: 2 descendants cleared2015: 18 descendants cleared2014: 16 descendants cleared2017: 13 descendants cleared2025: 20 descendants cleared2022: 13 descendants cleared2016: 11 descendants cleared2026: 22 descendants cleared2011: 3 descendants cleared2020: 16 descendants cleared2024: 24 descendants cleared200020052010201520202025
  1. This deviceK003590 Grams Polyester Nonabsorbable SutureGramsmed, LLC · 2001
  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 281 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12003: 22004: 42005: 22006: 12007: 52008: 22009: 82010: 52011: 32012: 72013: 102014: 162015: 182016: 112017: 132018: 122019: 202020: 162021: 192022: 132023: 262024: 242025: 202026: 22
2001high 26 (2023) · low 1 (2001)2026

Most influential descendants

Showing 5 of 281 · 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)K003590Grams Polyester Nonabsorbable SutureGramsmed, LLC2001—
+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
200320
200440
200520
200610
200750
200820
200980
201050
201130
201270
2013100
2014160
2015180
2016110
2017130
2018120
2019200
2020160
2021190
2022130
2023260
2024240
2025200
2026220
FIG. 1 — Lineage of K003590, 2001–2026Source: 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? (281)

See all 281

4 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
K023030Demetech Polyester Nonabsorbable SutureDemetech Corp.200319

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, 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 Gramsmed, LLC

7 FDA decisions under this applicant name. See the company

  • K021043Grams Absorbable Surgical Gut Suture Plain & ChromicGramsmed, LLC · 2002
  • K010672Monograms Synthetic Monofilament Absorbable SutureGramsmed, LLC · 2001
  • K003017Gramsorb Synthetic Absorbable SutureGramsmed, LLC · 2001
  • K002999Grams Polypropylene Nonabsorbable SutureGramsmed, LLC · 2000
  • K003000Grams Nylon Nonabsorbable SutureGramsmed, LLC · 2000

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https://510kreport.com/device/K003590 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003590: Grams Polyester 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/K003590

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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