510(k) · Cleared
ClearedMersilk Black Silk Braided Non-Absorbable Suture, Usp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Medical (China), Ltd. · GAP Suture, Nonabsorbable, Silk
Cleared on Sep 19, 2001 as substantially equivalent to K000541 (Arc Medical Supplies (Beijing) Co, Ltd., 2000) after a 75-day review. Its family tree reaches back 1 generation to 2000. 39 later devices descend from it.
- Decided
- Sep 19, 2001
- Review
- 75 days
- Class
- Class II
- Product code
- GAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000541 (2000). 39 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000541 Silk Nonabsorbable Surgical Sutures, UspArc Medical Supplies (Beijing) Co, Ltd. · 2000
- This deviceK012124 Mersilk Black Silk Braided Non-Absorbable Suture, UspJohnson & Johnson Medical (China), Ltd. · 2001
- Descendant · cites it directly · 37 of its ownK032245 Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex…Arthrex, Inc. · 2004
- Descendant · 2 generations on · 31 of its ownK041553 Arthrex Suture Grafting KitArthrex, Inc. · 2004
- Descendant · 3 generations on · 13 of its ownK122374 Arthrex Suture (Uhmwpe)Arthrex, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK143702 Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK041589 Arthrex Fiberwire with SilkArthrex, Inc. · 2004
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K032245Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM…Arthrex, Inc. · 2004 · cites it directly37descendants
- K041553Arthrex Suture Grafting KitArthrex, Inc. · 2004 · 2 generations on31descendants
- K122374Arthrex Suture (Uhmwpe)Arthrex, Inc. · 2012 · 3 generations on13descendants
- K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc. · 2015 · 2 generations on4descendants
- K041589Arthrex Fiberwire with SilkArthrex, Inc. · 2004 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000541 | Silk Nonabsorbable Surgical Sutures, Usp | Arc Medical Supplies (Beijing) Co, Ltd. | 2000 | — |
| 0 (this device) | K012124 | Mersilk Black Silk Braided Non-Absorbable Suture, Usp | Johnson & Johnson Medical (China), Ltd. | 2001 | — |
| +1 | K032245 | Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape… | Arthrex, Inc. | 2004 | — |
| +2 | K041553 | Arthrex Suture Grafting Kit | Arthrex, Inc. | 2004 | — |
| +3 | K122374 | Arthrex Suture (Uhmwpe) | Arthrex, Inc. | 2012 | — |
| +2 | K143702 | Arthrex Blunt Tip Screws with Fiber Tape | Arthrex, Inc. | 2015 | — |
| +1 | K041589 | Arthrex Fiberwire with Silk | Arthrex, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 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? (1)
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 |
|---|---|---|---|
| * | K000541 | Silk Nonabsorbable Surgical Sutures, UspSummary page 1…k Braided Non-absorbable suture, USP. Predicate Device Information: ARC Medical Supplies (beijing) Co., Ltd.. Silk Nonabsorbable Surgical Suture, USP. 510(K) number is K000541. Device Description: The black silk braided nonabsorbable sutures, USP, manufactured by Johnson & Johnson Medical (China) Ltd.… | 2000 |
What descends from it? (39)
See all 392 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?
- Its one ancestor has no recall.
- Of its descendants, K032245 (Arthrex, Inc., 2004) has gone furthest, with 37 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 | — |
What is it indicated for?
Silk suture is indicated for use in general soft tissue approximation and for 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/K012124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012124: Mersilk Black Silk Braided Non-Absorbable Suture, Usp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012124
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026