510(k) · Cleared
ClearedModification to Sparc 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 May 15, 2002 as substantially equivalent to K011251 (American Medical Systems, Inc., 2001) and 2 other predicates after a 23-day review. Its family tree reaches back 3 generations to 2001. 109 later devices descend from it.
- Decided
- May 15, 2002
- Review
- 23 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K011251 (2001). 109 later devices descend from it, 10 citing it directly.
- Root · 3 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 2 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 1 generation backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- This deviceK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- Descendant · cites it directly · 102 of its ownK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
- Descendant · cites it directly · 81 of its ownK030123 Bioarc SP Sling KitAmerican Medical Systems, Inc. · 2003
- Descendant · 2 generations on · 70 of its ownK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- Descendant · 2 generations on · 70 of its ownK040537 Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004
- Descendant · 2 generations on · 39 of its ownK040538 Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996American Medical Systems, Inc. · 2004
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 109 · See all- K023516Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · cites it directly102descendants
- K030123Bioarc SP Sling KitAmerican Medical Systems, Inc. · 2003 · cites it directly81descendants
- K040623Ams Perigee SystemAmerican Medical Systems, Inc. · 2004 · 2 generations on70descendants
- K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004 · 2 generations on70descendants
- K040538Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996American Medical Systems, Inc. · 2004 · 2 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −2 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −1 | K020663 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| 0 (this device) | K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| +1 | K023516 | Monarc Sling System | American Medical Systems, Inc. | 2002 | 1 |
| +1 | K030123 | Bioarc SP Sling Kit | American Medical Systems, Inc. | 2003 | — |
| +2 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| +2 | K040537 | Ams Apogee Vault Suspension System | American Medical Systems, Inc. | 2004 | — |
| +2 | K040538 | Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996 | American Medical Systems, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 15 | 0 |
| 2009 | 10 | 0 |
| 2010 | 5 | 0 |
| 2011 | 9 | 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? (3)
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…Surgical Mesh, Sling, Urethral Sling Device Trade Name: SPARC™ Sling System Device Classification Name: Surgical Mesh, polymeric Predicate Device: SPARC™ Sling System — K011251, K013355, K020663 Device Description The SPARC“" Sling System as currently marketed is a sterile, single use procedure kit co… | 2001 |
| * | K013355 | Sparc Sling SystemSummary page 1…Mesh, Sling, Urethral Sling Device Trade Name: SPARC™ Sling System Device Classification Name: Surgical Mesh, polymeric Predicate Device: SPARC™ Sling System — K011251, K013355, K020663 Device Description The SPARC“" Sling System as currently marketed is a sterile, single use procedure kit consisting… | 2001 |
| * | K020663 | Modification to Sparc Sling SystemSummary page 1…ng, Urethral Sling Device Trade Name: SPARC™ Sling System Device Classification Name: Surgical Mesh, polymeric Predicate Device: SPARC™ Sling System — K011251, K013355, K020663 Device Description The SPARC“" Sling System as currently marketed is a sterile, single use procedure kit consisting of: Two s… | 2002 |
What descends from it? (109)
See all 10910 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023516 | Monarc Sling System | 2002 | 102 |
| K030123 | Bioarc SP Sling Kit | 2003 | 81 |
| K041948 | Sparc, Monarc, Bioarc SP and Bioarc to Sling Systems | 2004 | 37 |
| K051485 | Ams Pelvic Floor Repair System | 2005 | 17 |
| K023898 | Gyne Ideas Minitape RP Device | 2003 | 4 |
| K073646 | Minitape Urethral Sling | 2008 | 2 |
| K053296 | Mentor Aris Suprapubic Surgical Kit | 2005 | 2 |
| K091180 | Minitape Urethral Sling | 2009 | 1 |
| K073647 | Minitape Extra Urethral Sling | 2008 | 1 |
| K092203 | Omnisure Urethral Sling, Model OTK52 | 2009 | 0 |
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 1 year and passes through 1 company; a new generation was cleared every 3 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K023516 (American Medical Systems, Inc., 2002) has gone furthest, with 102 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 SPARC™ 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/K021263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021263: Modification to Sparc 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/K021263
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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