510(k) · Cleared
Recalled · Class II · 2014Sparc System and Monarc, Monarc, and Monarc C Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Systems · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Dec 5, 2013 as substantially equivalent to K081613 (American Medical Systems, Inc., 2008) after a 219-day review. Its family tree reaches back 8 generations to 2001. It has been recalled once.
- Decided
- Dec 5, 2013
- Review
- 219 days
- Class
- Class II
- Product code
- OTN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K011251 (2001). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 7 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 6 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 5 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 4 generations backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
- 3 generations backK040538 Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996American Medical Systems, Inc. · 2004
- 2 generations backK041948 Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsAmerican Medical Systems, Inc. · 2004
- 1 generation backK081613 Sparc System / Monarc, Monarc C, Monarc + SystemsAmerican Medical Systems, Inc. · 2008
- This deviceK131229 Sparc System and Monarc, Monarc, and Monarc C SystemsAmerican Medical Systems · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −7 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −6 | K020663 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −5 | K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −4 | K023516 | Monarc Sling System | American Medical Systems, Inc. | 2002 | 1 |
| −3 | K040538 | Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996 | American Medical Systems, Inc. | 2004 | — |
| −2 | K041948 | Sparc, Monarc, Bioarc SP and Bioarc to Sling Systems | American Medical Systems, Inc. | 2004 | — |
| −1 | K081613 | Sparc System / Monarc, Monarc C, Monarc + Systems | American Medical Systems, Inc. | 2008 | — |
| 0 (this device) | K131229 | Sparc System and Monarc, Monarc, and Monarc C Systems | American Medical Systems | 2013 | — |
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 |
|---|---|---|---|
| * | K081613 | Sparc System / Monarc, Monarc C, Monarc + SystemsSummary page 2…21 CFR 878.3300 Product Code: OTN Predicate Devices: Sparc Sling System (Sparc) and Monarc, Monarc + and Monarc C Subfascial Hammock (Monarc) device; K081613 Proposed Device Description: The Sparc and Monarc related device descriptions are as followed: The Sparc device is a sterile, si… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2014 | Class II | Z-0805-2015 | Nonconforming Material/Component | During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components supplied with the AdVance" Male Sling System; Model #… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- 2 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K081613.
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. 2013, 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?
Sparc System:
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.
Monarc, Monarc + and Monarc C Systems:
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131229: Sparc System and Monarc, Monarc, and Monarc C Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131229
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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