510(k) · Cleared
ClearedSparc, Monarc, Bioarc SP and Bioarc to Sling 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 Aug 11, 2004 as substantially equivalent to K021263 (American Medical Systems, Inc., 2002) and 3 other predicates after a 22-day review. Its family tree reaches back 6 generations to 2001. 37 later devices descend from it.
- Decided
- Aug 11, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K011251 (2001). 7 ancestors in all. 37 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 5 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 4 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 3 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 2 generations backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
- 1 generation backK040538 Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996American Medical Systems, Inc. · 2004
- This deviceK041948 Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsAmerican Medical Systems, Inc. · 2004
- Descendant · cites it directly · 30 of its ownK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 17 of its ownK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
- Descendant · 2 generations on · 12 of its ownK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008
- Descendant · 3 generations on · 11 of its ownK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012
- Descendant · 3 generations on · 11 of its ownK080185 Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate…American Medical Systems, Inc. · 2008
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · cites it directly30descendants
- K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005 · 2 generations on17descendants
- K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc. · 2008 · 2 generations on12descendants
- K120019Collagen RibbonWrightmedicaltechnologyinc · 2012 · 3 generations on11descendants
- K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc. · 2008 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −5 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −4 | K020663 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −3 | K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −2 | K023516 | Monarc Sling System | American Medical Systems, Inc. | 2002 | 1 |
| −1 | K040538 | Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996 | American Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K041948 | Sparc, Monarc, Bioarc SP and Bioarc to Sling Systems | American Medical Systems, Inc. | 2004 | — |
| +1 | K050445 | Ams Collagen Dermal Matrix | American Medical Systems, Inc. | 2005 | 1 |
| +2 | K051485 | Ams Pelvic Floor Repair System | American Medical Systems, Inc. | 2005 | — |
| +2 | K073219 | WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal… | American Medical Systems, Inc. | 2008 | — |
| +3 | K120019 | Collagen Ribbon | Wrightmedicaltechnologyinc | 2012 | — |
| +3 | K080185 | Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen… | American Medical Systems, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K021263 | Modification to Sparc Sling SystemSummary page 1…MONARC™, BioArc SP™, and BioArc TO™ Sling Systems Common Name: Surgical Mesh Device Product Code & Classification: Class Il; OT N Predicate Device: SPARC™ Sling System (K021263) MONARC™ Sling System (K023516) BioArc SP™ Sling System (K030123) BioArc TO™ Sling System (K040538) Device Description: The SP… | 2002 |
| * | K023516 | Monarc Sling SystemSummary page 1…TO™ Sling Systems Common Name: Surgical Mesh Device Product Code & Classification: Class Il; OT N Predicate Device: SPARC™ Sling System (K021263) MONARC™ Sling System (K023516) BioArc SP™ Sling System (K030123) BioArc TO™ Sling System (K040538) Device Description: The SPARC™, MONARC™, BioArc SP™, and B… | 2002 |
| * | K030123 | Bioarc SP Sling KitSummary page 1…rgical Mesh Device Product Code & Classification: Class Il; OT N Predicate Device: SPARC™ Sling System (K021263) MONARC™ Sling System (K023516) BioArc SP™ Sling System (K030123) BioArc TO™ Sling System (K040538) Device Description: The SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems are steril… | 2003 |
| * | K040538 | Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996Summary page 1…Classification: Class Il; OT N Predicate Device: SPARC™ Sling System (K021263) MONARC™ Sling System (K023516) BioArc SP™ Sling System (K030123) BioArc TO™ Sling System (K040538) Device Description: The SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems are sterile, single use procedure kits that… | 2004 |
What descends from it? (37)
See all 372 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 3 years and passes through 1 company; a new generation was cleared every 5 months on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K050445 (American Medical Systems, Inc., 2005) has gone furthest, with 30 descendants of its own.
- 9 other devices also cite its predicate K021263.
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 SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems are 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/K041948 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041948: Sparc, Monarc, Bioarc SP and Bioarc to Sling Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041948
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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