510(k) · Cleared
ClearedSilk Nonabsorbable Surgical Sutures, Usp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arc Medical Supplies (Beijing) Co, Ltd. · GAP Suture, Nonabsorbable, Silk
Cleared on Apr 28, 2000 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 40 later devices descend from it.
- Decided
- Apr 28, 2000
- Review
- 71 days
- Class
- Class II
- Product code
- GAP
- Recalls
- None
- Predicates
- 0
40 later devices descend from it, 1 citing it directly.
- This deviceK000541 Silk Nonabsorbable Surgical Sutures, UspArc Medical Supplies (Beijing) Co, Ltd. · 2000
- Descendant · cites it directly · 39 of its ownK012124 Mersilk Black Silk Braided Non-Absorbable Suture, UspJohnson & Johnson Medical (China), Ltd. · 2001
- Descendant · 2 generations on · 37 of its ownK032245 Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex…Arthrex, Inc. · 2004
- Descendant · 3 generations on · 31 of its ownK041553 Arthrex Suture Grafting KitArthrex, Inc. · 2004
- Descendant · 4 generations on · 13 of its ownK122374 Arthrex Suture (Uhmwpe)Arthrex, Inc. · 2012
- Descendant · 3 generations on · 4 of its ownK143702 Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc. · 2015
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K012124Mersilk Black Silk Braided Non-Absorbable Suture, UspJohnson & Johnson Medical (China), Ltd. · 2001 · cites it directly39descendants
- K032245Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM…Arthrex, Inc. · 2004 · 2 generations on37descendants
- K041553Arthrex Suture Grafting KitArthrex, Inc. · 2004 · 3 generations on31descendants
- K122374Arthrex Suture (Uhmwpe)Arthrex, Inc. · 2012 · 4 generations on13descendants
- K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc. · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000541 | Silk Nonabsorbable Surgical Sutures, Usp | Arc Medical Supplies (Beijing) Co, Ltd. | 2000 | — |
| +1 | K012124 | Mersilk Black Silk Braided Non-Absorbable Suture, Usp | Johnson & Johnson Medical (China), Ltd. | 2001 | — |
| +2 | K032245 | Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape… | Arthrex, Inc. | 2004 | — |
| +3 | K041553 | Arthrex Suture Grafting Kit | Arthrex, Inc. | 2004 | — |
| +4 | K122374 | Arthrex Suture (Uhmwpe) | Arthrex, Inc. | 2012 | — |
| +3 | K143702 | Arthrex Blunt Tip Screws with Fiber Tape | Arthrex, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 0 |
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 GAP? 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 GAP device
- #1 K222944 SafePath Sulturing System-Silk Suture…score 9.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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? (40)
See all 401 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012124 | Mersilk Black Silk Braided Non-Absorbable Suture, Usp | 2001 | 39 |
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, K012124 (Johnson & Johnson Medical (China), Ltd., 2001) has gone furthest, with 39 descendants of its own.
How does its category compare?
All GAP devicesGAP Suture, Nonabsorbable, Silk: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAP
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GAP
193in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAP
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAP
478in 2025
MAUDE reports naming product code GAP, 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 | 1 | — | 0 | 7 |
| 2008 | 1 | — | 0 | 21 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 21 | 6 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 1 | 15 |
| 2015 | 0 | — | 0 | 25 |
| 2016 | 2 | — | 0 | 54 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 1 | — | 1 | 340 |
| 2019 | 0 | — | 0 | 333 |
| 2020 | 0 | — | 0 | 426 |
| 2021 | 0 | — | 0 | 437 |
| 2022 | 0 | — | 0 | 419 |
| 2023 | 1 | — | 1 | 404 |
| 2024 | 3 | 193 | 0 | 455 |
| 2025 | 0 | — | 0 | 478 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K000541 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000541: Silk Nonabsorbable Surgical Sutures, Usp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000541
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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