510(k) · Cleared
ClearedSilkam Nonabsorbable Silk Surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GAP Suture, Nonabsorbable, Silk
Cleared on Mar 15, 1999 after a 63-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Mar 15, 1999
- Review
- 63 days
- Class
- Class II
- Product code
- GAP
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 2 citing it directly.
- This deviceK990089 Silkam Nonabsorbable Silk Surgical SutureAesculap, Inc. · 1999
- Descendant · cites it directly · 13 of its ownK041514 Truesilk Non-Absorbable Silk Surgical SutureSutures India Private Limited · 2005
- Descendant · 2 generations on · 9 of its ownK080684 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
- Descendant · 3 generations on · 4 of its ownK161633 Rexlon, RexsilSm Eng Co., Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK160623 FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE -…M/s. Meril Endo Surgery Private Limited. · 2016
- Descendant · 3 generations on · 1 of its ownK173747 RexleneSm Eng Co., Ltd. · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K041514Truesilk Non-Absorbable Silk Surgical SutureSutures India Private Limited · 2005 · cites it directly13descendants
- K080684WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008 · 2 generations on9descendants
- K161633Rexlon, RexsilSm Eng Co., Ltd. · 2017 · 3 generations on4descendants
- K160623FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…M/s. Meril Endo Surgery Private Limited. · 2016 · 2 generations on2descendants
- K173747RexleneSm Eng Co., Ltd. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990089 | Silkam Nonabsorbable Silk Surgical Suture | Aesculap, Inc. | 1999 | — |
| +1 | K041514 | Truesilk Non-Absorbable Silk Surgical Suture | Sutures India Private Limited | 2005 | — |
| +2 | K080684 | WG-Surgical Sutures with Needle | Foosin Medical Supplies, Inc. | 2008 | — |
| +3 | K161633 | Rexlon, Rexsil | Sm Eng Co., Ltd. | 2017 | — |
| +2 | K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non… | M/s. Meril Endo Surgery Private Limited. | 2016 | — |
| +3 | K173747 | Rexlene | Sm Eng Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | — | Perma-Hand® Nonabsorbable Silk Surgical Suture Named without a submission number | |
| * | — | Nonabsorbable Silk Surgical Suture (Davis & Geck) Named without a submission number | |
| * | — | SOFSILK® Nonabsorbable Silk Surgical Suture Named without a submission number |
What descends from it? (14)
See all 142 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, K041514 (Sutures India Private Limited, 2005) has gone furthest, with 13 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?
Silkam® 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/K990089 · printed Nov 3, 2026
Cite this page
510(k) Report. “K990089: Silkam Nonabsorbable Silk Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K990089
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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