510(k) · Cleared
Recalled · 2003Monarc Sling System
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 Nov 19, 2002 as substantially equivalent to K011251 (American Medical Systems, Inc., 2001) and 3 other predicates after a 29-day review. Its family tree reaches back 4 generations to 2001. 102 later devices descend from it. It has been recalled once.
- Decided
- Nov 19, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- OTN
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K011251 (2001). 102 later devices descend from it, 10 citing it directly.
- Root · 4 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 3 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 2 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 1 generation backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- This deviceK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002
- Descendant · cites it directly · 70 of its ownK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- Descendant · cites it directly · 70 of its ownK040537 Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004
- Descendant · cites it directly · 39 of its ownK040538 Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996American Medical Systems, Inc. · 2004
- Descendant · cites it directly · 37 of its ownK041948 Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsAmerican Medical Systems, Inc. · 2004
- Descendant · 2 generations on · 30 of its ownK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 102 · See all- K040623Ams Perigee SystemAmerican Medical Systems, Inc. · 2004 · cites it directly70descendants
- K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004 · cites it directly70descendants
- K040538Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996American Medical Systems, Inc. · 2004 · cites it directly39descendants
- K041948Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsAmerican Medical Systems, Inc. · 2004 · cites it directly37descendants
- K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · 2 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −3 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −2 | K020663 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −1 | K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| 0 (this device) | K023516 | Monarc Sling System | American Medical Systems, Inc. | 2002 | — |
| +1 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| +1 | K040537 | Ams Apogee Vault Suspension System | American Medical Systems, Inc. | 2004 | — |
| +1 | 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 | — |
| +2 | K050445 | Ams Collagen Dermal Matrix | American Medical Systems, Inc. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 13 | 0 |
| 2009 | 10 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 14 | 0 |
| 2013 | 7 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K011251 | Sparc Sling SystemSummary page 1…930-6496 David Worrell October 15th, 2002 Surgical Mesh, Sling, Urethral Sling MONARC™ Sling System Surgical Mesh, polymeric Predicate Device: SPARC™ Sling System — K011251, K013355, K020663, K021263 Device Description The MONARC Sling System is a sterile, single use procedure kit consisting of two… | 2001 |
| * | K013355 | Sparc Sling SystemSummary page 1…David Worrell October 15th, 2002 Surgical Mesh, Sling, Urethral Sling MONARC™ Sling System Surgical Mesh, polymeric Predicate Device: SPARC™ Sling System — K011251, K013355, K020663, K021263 Device Description The MONARC Sling System is a sterile, single use procedure kit consisting of two stainless… | 2001 |
| * | K020663 | Modification to Sparc Sling SystemSummary page 1…rell October 15th, 2002 Surgical Mesh, Sling, Urethral Sling MONARC™ Sling System Surgical Mesh, polymeric Predicate Device: SPARC™ Sling System — K011251, K013355, K020663, K021263 Device Description The MONARC Sling System is a sterile, single use procedure kit consisting of two stainless steel, 22… | 2002 |
| * | K021263 | Modification to Sparc Sling SystemSummary page 1…ober 15th, 2002 Surgical Mesh, Sling, Urethral Sling MONARC™ Sling System Surgical Mesh, polymeric Predicate Device: SPARC™ Sling System — K011251, K013355, K020663, K021263 Device Description The MONARC Sling System is a sterile, single use procedure kit consisting of two stainless steel, 22cm spiral… | 2002 |
What descends from it? (102)
See all 10210 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040623 | Ams Perigee System | 2004 | 70 |
| K040537 | Ams Apogee Vault Suspension System | 2004 | 70 |
| K040538 | Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996 | 2004 | 39 |
| K041948 | Sparc, Monarc, Bioarc SP and Bioarc to Sling Systems | 2004 | 37 |
| K070065 | Ams Single Incision Sling System (Sis-0) | 2007 | 17 |
| K051485 | Ams Pelvic Floor Repair System | 2005 | 17 |
| K053371 | Ams Male Transobturator Sling System | 2006 | 10 |
| K051530 | Monarc + Subfascial Hammock, Model 72404193; Monarc C Subfascial Hammock, Model 72404195. | 2005 | 6 |
| K063713 | Ams Smart Sling System | 2007 | 1 |
| K051533 | I-STOP | 2005 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 28, 2003 | Not classified | Z-1019-04 | Other | Insertion needles from the former version of the product were packaged with the new sling with dilator that is different than the old version and not compatible with the old needles. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 1 year and passes through 1 company; a new generation was cleared every 5 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K040623 (American Medical Systems, Inc., 2004) has gone furthest, with 70 descendants of its own.
- 12 other devices also cite its predicate K011251.
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 MONARC™ Sling System is intended for the placement of a 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/K023516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023516: Monarc 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/K023516
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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