510(k) · Cleared
ClearedModification to Surgical Mesh Polymeric
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Apr 14, 2004 as substantially equivalent to K020110 (Boston Scientific, 2002) after a 16-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it.
- Decided
- Apr 14, 2004
- Review
- 16 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945377 (1994). 5 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK945377 Trelex Natural (R) MeshMeadox Medicals, Div. Boston Scientific Corp. · 1994
- 1 generation backK020110 Modification to Trelex Mesh Surgical MeshBoston Scientific · 2002
- This deviceK040787 Modification to Surgical Mesh PolymericBoston Scientific · 2004
- Descendant · cites it directly · 3 of its ownK121754 Blue Sui SlingBoston Scientific Corp · 2012
- Descendant · 2 generations on · 1 of its ownK211223 Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation · 2021
- Descendant · 3 generations on · 0 of its ownK231549 Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK172565 Advantage/Advantage Fit Delivery Device, Lynx Delivery Device…Boston Scientific Corporation · 2017
Most influential descendants
Showing 4 of 4 · See all- K121754Blue Sui SlingBoston Scientific Corp · 2012 · cites it directly3descendants
- K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation · 2021 · 2 generations on1descendant
- K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation · 2023 · 3 generations on0descendants
- K172565Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device…Boston Scientific Corporation · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945377 | Trelex Natural (R) Mesh | Meadox Medicals, Div. Boston Scientific Corp. | 1994 | — |
| −1 | K020110 | Modification to Trelex Mesh Surgical Mesh | Boston Scientific | 2002 | — |
| 0 (this device) | K040787 | Modification to Surgical Mesh Polymeric | Boston Scientific | 2004 | — |
| +1 | K121754 | Blue Sui Sling | Boston Scientific Corp | 2012 | — |
| +2 | K211223 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | Boston Scientific Corporation | 2021 | — |
| +3 | K231549 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | Boston Scientific Corporation | 2023 | — |
| +2 | K172565 | Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery… | Boston Scientific Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 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 OTN? 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 OTN device
- #1 K231549 Advantage Ultra System, Advantage Fit Ultra…score 6.8 · 5 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 |
|---|---|---|---|
| * | K020110 | Modification to Trelex Mesh Surgical MeshSummary page 1…s Common/usual name: Surgical Mesh Classification Name: OTN- Mesh, Surgical, Polymeric 21 CFR 878.3300, Class II Premarket Notification: Boston Scientific Corporation, = K020110 E. Device Description The proposed sling is a sterile, single use device, consisting of a synthetic mesh sling assembly and pack… | 2002 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121754 | Blue Sui Sling | 2012 | 3 |
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K121754 (Boston Scientific Corp, 2012) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K020110.
How does its category compare?
All OTN devicesOTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OTN
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OTN
89in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OTN
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OTN
458in 2025
MAUDE reports naming product code OTN, 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 | 2 | — | 0 | 0 |
| 2008 | 3 | 100 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 5 | 25 | 0 | 1 |
| 2011 | 4 | 56 | 0 | 25 |
| 2012 | 1 | — | 0 | 874 |
| 2013 | 5 | 86 | 0 | 19,084 |
| 2014 | 1 | — | 1 | 2,063 |
| 2015 | 0 | — | 0 | 3,904 |
| 2016 | 0 | — | 0 | 1,902 |
| 2017 | 1 | — | 0 | 676 |
| 2018 | 0 | — | 0 | 737 |
| 2019 | 1 | — | 0 | 2,457 |
| 2020 | 1 | — | 0 | 1,003 |
| 2021 | 3 | 89 | 0 | 2,606 |
| 2022 | 2 | — | 0 | 809 |
| 2023 | 1 | — | 0 | 1,076 |
| 2024 | 0 | — | 0 | 822 |
| 2025 | 0 | — | 0 | 458 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
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/K040787 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040787: Modification to Surgical Mesh Polymeric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040787
Report an extraction error
Are you the manufacturer?
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