510(k) · Cleared
ClearedAdvantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Jun 29, 2023 as substantially equivalent to K211223 (Boston Scientific Corporation, 2021) after a 30-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Jun 29, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945377 (1994). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK945377 Trelex Natural (R) MeshMeadox Medicals, Div. Boston Scientific Corp. · 1994
- 4 generations backK020110 Modification to Trelex Mesh Surgical MeshBoston Scientific · 2002
- 3 generations backK040787 Modification to Surgical Mesh PolymericBoston Scientific · 2004
- 2 generations backK121754 Blue Sui SlingBoston Scientific Corp · 2012
- 1 generation backK211223 Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation · 2021
- This deviceK231549 Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945377 | Trelex Natural (R) Mesh | Meadox Medicals, Div. Boston Scientific Corp. | 1994 | — |
| −4 | K020110 | Modification to Trelex Mesh Surgical Mesh | Boston Scientific | 2002 | — |
| −3 | K040787 | Modification to Surgical Mesh Polymeric | Boston Scientific | 2004 | — |
| −2 | K121754 | Blue Sui Sling | Boston Scientific Corp | 2012 | — |
| −1 | K211223 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | Boston Scientific Corporation | 2021 | — |
| 0 (this device) | K231549 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | Boston Scientific Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2001 | 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 K222293 ArcSP Suprapubic Sling Systemscore 6.7 · 10 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 |
|---|---|---|---|
| * | K211223 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemSummary page 5…s II Product Code: OTN 510(k) Submitter/Holder: Boston Scientific Corporation, Marlborough, MA 510(k) #/ Clearance Date K211223 / Cleared July 21, 2021 E. Device Description Advantage Ultra System and Advantage Fit Ultra System The Advantage Ultra System… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- None of the 8 ancestors has a recall.
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. 2023, this device’s year, is highlighted.
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?
Advantage Ultra System and Advantage Fit Ultra System The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The Advantage Ultra System and the Advantage Fit Ultra System delivery devices are intended for use as an aid in insertion, placement, fixation, and anchoring of the Advantage Ultra surgical mesh during…
Read the full statement (127 words)
Advantage Ultra System and Advantage Fit Ultra System
The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The Advantage Ultra System and the Advantage Fit Ultra System delivery devices are intended for use as an aid in insertion, placement, fixation, and anchoring of the Advantage Ultra surgical mesh during urogynecological procedures.
Lynx Ultra System
The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The Lynx Ultra System delivery device is intended for use as an aid in insertion, placement, fixation, and anchoring of the Lynx Ultra surgical mesh during urogynecological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231549: Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231549
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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