510(k) · Cleared
ClearedSynthofil Nonabsorbable Pet Surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Feb 10, 1999 after a 30-day review. The FDA summary names its predicate without a number. 275 later devices descend from it.
- Decided
- Feb 10, 1999
- Review
- 30 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 0
275 later devices descend from it, 3 citing it directly.
- This deviceK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
- Descendant · cites it directly · 260 of its ownK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
- Descendant · 2 generations on · 259 of its ownK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
- Descendant · 2 generations on · 161 of its ownK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 143 of its ownK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
- Descendant · 3 generations on · 69 of its ownK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
Showing 5 of 275 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 275 · See all- K012923Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001 · cites it directly260descendants
- K021434Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002 · 2 generations on259descendants
- 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 · 3 generations on69descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990088 | Synthofil Nonabsorbable Pet Surgical Suture | Aesculap, Inc. | 1999 | — |
| +1 | K012923 | Arthrex Fiberwire, Usp Size 5, Model AR-7201 | Arthrex, Inc. | 2001 | — |
| +2 | K021434 | Arthrex Fiberwire in Usp Sizes | Arthrex, Inc. | 2002 | — |
| +2 | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS | Arthrex, Inc. | 2003 | 1 |
| +3 | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM | Arthrex, Inc. | 2006 | — |
| +3 | K063778 | Force Fiber Polyethylene Nonabsorbable Suture | Teleflex Medical | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 8 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 6 | 0 |
| 2013 | 10 | 0 |
| 2014 | 16 | 0 |
| 2015 | 17 | 0 |
| 2016 | 9 | 0 |
| 2017 | 11 | 0 |
| 2018 | 12 | 0 |
| 2019 | 19 | 0 |
| 2020 | 16 | 0 |
| 2021 | 18 | 0 |
| 2022 | 13 | 0 |
| 2023 | 26 | 0 |
| 2024 | 26 | 0 |
| 2025 | 20 | 0 |
| 2026 | 20 | 0 |
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 K230311 HyperSuturescore 20.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Ethibond® Nonabsorbable Polyester Surgical Suture (Ethicon, Inc.) Named without a submission number | |
| * | — | Ti-Cron® Nonabsorbable Polyester Surgical Suture (Davis & Geck) Named without a submission number | |
| * | — | SURGIDAC® Nonabsorbable PET Surgical Suture (U. S. Surgical Corp.) Named without a submission number |
What descends from it? (275)
See all 2753 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
Synthofil® sutures are intended for use in general soft tissue
approximation and/or ligation, including use in cardiovascular,
ophthalmic and neurological procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990088 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990088: Synthofil Nonabsorbable Pet Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990088
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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