510(k) · Cleared
ClearedPolyform Synthetic Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Cleared on Dec 15, 2017 as substantially equivalent to K051245 (Proxy Biomedical, Ltd., 2005) after a 228-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Dec 15, 2017
- Review
- 228 days
- Class
- Class II
- Product code
- OTO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051245 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK051245 Polyform Synthetic MeshProxy Biomedical, Ltd. · 2005
- This deviceK171271 Polyform Synthetic MeshBoston Scientific Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051245 | Polyform Synthetic Mesh | Proxy Biomedical, Ltd. | 2005 | — |
| 0 (this device) | K171271 | Polyform Synthetic Mesh | Boston Scientific Corporation | 2017 | — |
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? (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 |
|---|---|---|---|
| * | K051245 | Polyform Synthetic MeshSummary page 4…tic, Urogynecologic, For Apical Vaginal and Uterine Prolapse, Trasabdominally Placed Predicate: Polyform™ Synthetic Mesh (K051245) The predicate device has not been subject to a design related recall. E. Device Description The subject device co… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K051245.
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. 2017, this device’s year, is highlighted.
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 as stated in the FDA summary.
https://510kreport.com/device/K171271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171271: 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/K171271
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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