510(k) · Cleared
ClearedSparc System / Monarc, Monarc C, Monarc + Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Systems, Inc. · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Sep 17, 2008 as substantially equivalent to K041948 (American Medical Systems, Inc., 2004) and 1 other predicate after a 100-day review. Its family tree reaches back 7 generations to 2001. 5 later devices descend from it.
- Decided
- Sep 17, 2008
- Review
- 100 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K011251 (2001). 9 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 6 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 5 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 4 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 3 generations backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
- 2 generations backK040538 Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996American Medical Systems, Inc. · 2004
- 1 generation backK041948 Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsAmerican Medical Systems, Inc. · 2004
- This deviceK081613 Sparc System / Monarc, Monarc C, Monarc + SystemsAmerican Medical Systems, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK132655 Retroarc Retropubic Sling SystemAmerican Medical Systems, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK183134 ArcTV Transvaginal Sling SystemUrocure, LLC · 2019
- Descendant · 3 generations on · 0 of its ownK222293 ArcSP Suprapubic Sling SystemUrocure, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK222468 ArcTO Transobturator Sling SystemUrocure, LLC · 2022
- Descendant · cites it directly · 0 of its ownK131229 Sparc System and Monarc, Monarc, and Monarc C SystemsAmerican Medical Systems · 2013 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K132655Retroarc Retropubic Sling SystemAmerican Medical Systems, Inc. · 2013 · cites it directly3descendants
- K183134ArcTV Transvaginal Sling SystemUrocure, LLC · 2019 · 2 generations on2descendants
- K222293ArcSP Suprapubic Sling SystemUrocure, LLC · 2022 · 3 generations on0descendants
- K222468ArcTO Transobturator Sling SystemUrocure, LLC · 2022 · 3 generations on0descendants
- K131229Sparc System and Monarc, Monarc, and Monarc C SystemsAmerican Medical Systems · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −6 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −5 | K020663 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −4 | K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −3 | K023516 | Monarc Sling System | American Medical Systems, Inc. | 2002 | 1 |
| −2 | K040538 | Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996 | American Medical Systems, Inc. | 2004 | — |
| −1 | K041948 | Sparc, Monarc, Bioarc SP and Bioarc to Sling Systems | American Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K081613 | Sparc System / Monarc, Monarc C, Monarc + Systems | American Medical Systems, Inc. | 2008 | — |
| +1 | K132655 | Retroarc Retropubic Sling System | American Medical Systems, Inc. | 2013 | — |
| +2 | K183134 | ArcTV Transvaginal Sling System | Urocure, LLC | 2019 | — |
| +3 | K222293 | ArcSP Suprapubic Sling System | Urocure, LLC | 2022 | — |
| +3 | K222468 | ArcTO Transobturator Sling System | Urocure, LLC | 2022 | — |
| +1 | K131229 | Sparc System and Monarc, Monarc, and Monarc C Systems | American Medical Systems | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 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? (2)
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 |
|---|---|---|---|
| * | K041948 | Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsSummary page 1…ystem, and Monarc® C System Device Classification/ Class 11, 21 CFR Part 878.3300 Classification Name: Surgical Mesh, polymeric (OTfl) Predicate Device: SPARC™ System (K041948), Monarc® System, Monarc® + System, and Monarc® C System (K051530) indications for Use Sparc System: Intended for the placemen… | 2004 |
| * | K051530 | Monarc + Subfascial Hammock, Model 72404193; Monarc C Subfascial Hammock, Model 72404195.Summary page 1…FR Part 878.3300 Classification Name: Surgical Mesh, polymeric (OTfl) Predicate Device: SPARC™ System (K041948), Monarc® System, Monarc® + System, and Monarc® C System (K051530) indications for Use Sparc System: Intended for the placement of pubourethral sling for the treatment of female stress urinary… | 2005 |
What descends from it? (5)
2 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?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 5 months on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K132655 (American Medical Systems, Inc., 2013) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K041948.
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. 2008, 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?
Intended for the placement of suburethral mesh for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and /or intrinsic sphincter deficiency.
Intended for the placement of pubourethral sling for the treatment of female stress urinary incontinence (SUI) 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/K081613 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081613: Sparc System / Monarc, Monarc C, Monarc + Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081613
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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