510(k) · Cleared
ClearedPolyform Synthetic Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Proxy Biomedical, Ltd. · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Cleared on Jun 17, 2005 after a 32-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Jun 17, 2005
- Review
- 32 days
- Class
- Class II
- Product code
- OTO
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK051245 Polyform Synthetic MeshProxy Biomedical, Ltd. · 2005
- Descendant · cites it directly · 7 of its ownK071957 Pinnacle Pelvic Floor Repair KitsBoston Scientific Corp · 2007 · Recalled
- Descendant · 2 generations on · 6 of its ownK081048 Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp · 2008 · Recalled
- Descendant · 2 generations on · 5 of its ownK091131 Pelvic Floor Repair SystemBoston Scientific · 2009
- Descendant · 2 generations on · 4 of its ownK103426 Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011
- Descendant · 3 generations on · 2 of its ownK122459 Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal…Boston Scientific Corporation · 2012 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K071957Pinnacle Pelvic Floor Repair KitsBoston Scientific Corp · 2007 · cites it directly7descendants
- K081048Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp · 2008 · 2 generations on6descendants
- K091131Pelvic Floor Repair SystemBoston Scientific · 2009 · 2 generations on5descendants
- K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011 · 2 generations on4descendants
- K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation · 2012 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051245 | Polyform Synthetic Mesh | Proxy Biomedical, Ltd. | 2005 | — |
| +1 | K071957 | Pinnacle Pelvic Floor Repair Kits | Boston Scientific Corp | 2007 | 3 |
| +2 | K081048 | Pinnacle Pelvic Floor Repair Kit II | Boston Scientific Corp | 2008 | 1 |
| +2 | K091131 | Pelvic Floor Repair System | Boston Scientific | 2009 | — |
| +2 | K103426 | Lite Pelvic Floor Repair Kits | Boston Scientific Corp | 2011 | — |
| +3 | K122459 | Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support… | Boston Scientific Corporation | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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 OTO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Mersilene Mesh Named without a submission number | |
| * | — | Prolene Soft Mesh Named without a submission number | |
| * | — | Bard Mesh Named without a submission number |
What descends from it? (9)
2 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?
- Of its descendants, K071957 (Boston Scientific Corp, 2007) has gone furthest, with 7 descendants of its own.
How does its category compare?
All OTO devicesOTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OTO
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · OTO
95in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OTO
No recall names OTO since 2007.
Adverse event reports per year · OTO
79in 2025
MAUDE reports naming product code OTO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 7 | 101 | 0 | 160 |
| 2013 | 4 | 95 | 0 | 2,272 |
| 2014 | 1 | — | 0 | 267 |
| 2015 | 2 | — | 0 | 448 |
| 2016 | 0 | — | 0 | 156 |
| 2017 | 1 | — | 0 | 75 |
| 2018 | 0 | — | 0 | 145 |
| 2019 | 0 | — | 0 | 347 |
| 2020 | 0 | — | 0 | 153 |
| 2021 | 0 | — | 0 | 292 |
| 2022 | 0 | — | 0 | 112 |
| 2023 | 0 | — | 0 | 101 |
| 2024 | 0 | — | 0 | 113 |
| 2025 | 0 | — | 0 | 79 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Polyform™ Synthetic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
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/K051245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051245: Polyform Synthetic Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051245
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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