510(k) · Cleared
ClearedMentor Aris Suprapubic Surgical Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Corporation · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Dec 15, 2005 as substantially equivalent to K050148 (Mentor Corporation, 2005) and 4 other predicates after a 20-day review. Its family tree reaches back 5 generations to 2001. 2 later devices descend from it.
- Decided
- Dec 15, 2005
- Review
- 20 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K011251 (2001). 8 ancestors in all, the oldest K974098 (1998). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 4 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 3 generations backK031767 Mentor Obtape Trans-Obturator TapeMentor Corp. · 2003
- 2 generations backK042851 Mentor Obtape Trans-Obturator Surgical KitMentor Corp. · 2004
- 1 generation backK050148 Mentor Aris Trans-Obturator Tape and Surgical KitMentor Corporation · 2005
- This deviceK053296 Mentor Aris Suprapubic Surgical KitMentor Corporation · 2005
- Descendant · cites it directly · 1 of its ownK111233 Supris Retropubic Sling SystemColoplast A/S · 2011
- Descendant · 2 generations on · 0 of its ownK242473 Altis Single Incision Sling System (519650); Aris Transobturator…Coloplast Corp. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −4 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −3 | K031767 | Mentor Obtape Trans-Obturator Tape | Mentor Corp. | 2003 | — |
| −2 | K042851 | Mentor Obtape Trans-Obturator Surgical Kit | Mentor Corp. | 2004 | — |
| −1 | K050148 | Mentor Aris Trans-Obturator Tape and Surgical Kit | Mentor Corporation | 2005 | — |
| 0 (this device) | K053296 | Mentor Aris Suprapubic Surgical Kit | Mentor Corporation | 2005 | — |
| +1 | K111233 | Supris Retropubic Sling System | Coloplast A/S | 2011 | — |
| +2 | K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System… | Coloplast Corp. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2024 | 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? (5)
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 |
|---|---|---|---|
| * | K050148 | Mentor Aris Trans-Obturator Tape and Surgical KitSummary page 1…ubic Surgical Kit is substantially equivalent in material, function, performance and design to thc Mentor Aris Trans-Obturator Tape and Surgical Kit cleared under 510(k) K050148, and to American Medical Systems’ SPARC Sling System cleared under 510(k)s K011251, K013355, K020663 and K021263. 000013 === Pa… | 2005 |
| * | K011251 | Sparc Sling SystemSummary page 1…d design to thc Mentor Aris Trans-Obturator Tape and Surgical Kit cleared under 510(k) K050148, and to American Medical Systems’ SPARC Sling System cleared under 510(k)s K011251, K013355, K020663 and K021263. 000013 }za § 329 é%- Indications for Use Mentor Aris Suprapubic Surgical Kit is… | 2001 |
| * | K013355 | Sparc Sling SystemSummary page 1…to thc Mentor Aris Trans-Obturator Tape and Surgical Kit cleared under 510(k) K050148, and to American Medical Systems’ SPARC Sling System cleared under 510(k)s K011251, K013355, K020663 and K021263. 000013 }za § 329 é%- Indications for Use Mentor Aris Suprapubic Surgical Kit is indicate… | 2001 |
| * | K020663 | Modification to Sparc Sling SystemSummary page 1…ntor Aris Trans-Obturator Tape and Surgical Kit cleared under 510(k) K050148, and to American Medical Systems’ SPARC Sling System cleared under 510(k)s K011251, K013355, K020663 and K021263. 000013 }za § 329 é%- Indications for Use Mentor Aris Suprapubic Surgical Kit is indicated for the… | 2002 |
| * | K021263 | Modification to Sparc Sling SystemSummary page 1…ans-Obturator Tape and Surgical Kit cleared under 510(k) K050148, and to American Medical Systems’ SPARC Sling System cleared under 510(k)s K011251, K013355, K020663 and K021263. 000013 }za § 329 é%- Indications for Use Mentor Aris Suprapubic Surgical Kit is indicated for the surgical tr… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111233 | Supris Retropubic Sling System | 2011 | 1 |
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 4 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K111233 (Coloplast A/S, 2011) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K050148.
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 Mentor Aris Suprapubic Surgical Kit is indicated for the surgical treatment of all types of stress urinary incontinence (SUI), and for female urinary incontinence 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/K053296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053296: Mentor Aris Suprapubic Surgical Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053296
Report an extraction error
Are you the manufacturer?
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