510(k) · Cleared
ClearedArcTO Transobturator Sling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Urocure, LLC · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Sep 15, 2022 as substantially equivalent to K183134 (Urocure, LLC, 2019) after a 30-day review. Its family tree reaches back 10 generations to 2001.
- Decided
- Sep 15, 2022
- Review
- 30 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K011251 (2001). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 6 generations between
- 3 generations backK081613 Sparc System / Monarc, Monarc C, Monarc + SystemsAmerican Medical Systems, Inc. · 2008
- 2 generations backK132655 Retroarc Retropubic Sling SystemAmerican Medical Systems, Inc. · 2013
- 1 generation backK183134 ArcTV Transvaginal Sling SystemUrocure, LLC · 2019
- This deviceK222468 ArcTO Transobturator Sling SystemUrocure, LLC · 2022
Show all 10 generations
- Root · 10 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 9 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 8 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 7 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 6 generations backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
- 5 generations backK040538 Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996American Medical Systems, Inc. · 2004
- 4 generations backK041948 Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsAmerican Medical Systems, Inc. · 2004
- 3 generations backK081613 Sparc System / Monarc, Monarc C, Monarc + SystemsAmerican Medical Systems, Inc. · 2008
- 2 generations backK132655 Retroarc Retropubic Sling SystemAmerican Medical Systems, Inc. · 2013
- 1 generation backK183134 ArcTV Transvaginal Sling SystemUrocure, LLC · 2019
- This deviceK222468 ArcTO Transobturator Sling SystemUrocure, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −9 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −8 | K020663 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −7 | K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −6 | K023516 | Monarc Sling System | American Medical Systems, Inc. | 2002 | 1 |
| −5 | K040538 | Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996 | American Medical Systems, Inc. | 2004 | — |
| −4 | K041948 | Sparc, Monarc, Bioarc SP and Bioarc to Sling Systems | American Medical Systems, Inc. | 2004 | — |
| −3 | K081613 | Sparc System / Monarc, Monarc C, Monarc + Systems | American Medical Systems, Inc. | 2008 | — |
| −2 | K132655 | Retroarc Retropubic Sling System | American Medical Systems, Inc. | 2013 | — |
| −1 | K183134 | ArcTV Transvaginal Sling System | Urocure, LLC | 2019 | — |
| 0 (this device) | K222468 | ArcTO Transobturator Sling System | Urocure, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K183134 | ArcTV Transvaginal Sling SystemSummary page 6…ArcTO Transobturator ArcTV Transvaginal Monarc Sling System Characteristics Sling System Sling System (K183134) (K131229) Same as predicate Implantable Sling… | 2019 |
| † | K131229 | Sparc System and Monarc, Monarc, and Monarc C Systems | 2013 |
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 21 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K183134.
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. 2022, 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?
The polypropylene sling is indicated to be placed mid-urethra for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222468: ArcTO Transobturator Sling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222468
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