510(k) · Cleared
Recalled · Class II · 2018Pinnacle Pelvic Floor Repair Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Cleared on Nov 8, 2007 as substantially equivalent to K051245 (Proxy Biomedical, Ltd., 2005) after a 115-day review. Its family tree reaches back 1 generation to 2005. 7 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 8, 2007
- Review
- 115 days
- Class
- Class III
- Product code
- OTP
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051245 (2005). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK051245 Polyform Synthetic MeshProxy Biomedical, Ltd. · 2005
- This deviceK071957 Pinnacle Pelvic Floor Repair KitsBoston Scientific Corp · 2007
- Descendant · cites it directly · 6 of its ownK081048 Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp · 2008 · Recalled
- Descendant · cites it directly · 5 of its ownK091131 Pelvic Floor Repair SystemBoston Scientific · 2009
- Descendant · cites it directly · 4 of its ownK103426 Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011
- Descendant · 2 generations on · 2 of its ownK122459 Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal…Boston Scientific Corporation · 2012 · Recalled
- Descendant · 3 generations on · 1 of its ownK172060 Capio SLIM Suture Capturing DeviceBoston Scientific Corporation · 2017 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K081048Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp · 2008 · cites it directly6descendants
- K091131Pelvic Floor Repair SystemBoston Scientific · 2009 · cites it directly5descendants
- K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011 · cites it directly4descendants
- K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation · 2012 · 2 generations on2descendants
- K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation · 2017 · 3 generations on1descendant
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) | K071957 | Pinnacle Pelvic Floor Repair Kits | Boston Scientific Corp | 2007 | — |
| +1 | K081048 | Pinnacle Pelvic Floor Repair Kit II | Boston Scientific Corp | 2008 | 1 |
| +1 | K091131 | Pelvic Floor Repair System | Boston Scientific | 2009 | — |
| +1 | K103426 | Lite Pelvic Floor Repair Kits | Boston Scientific Corp | 2011 | — |
| +2 | K122459 | Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support… | Boston Scientific Corporation | 2012 | 2 |
| +3 | K172060 | Capio SLIM Suture Capturing Device | Boston Scientific Corporation | 2017 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2017 | 1 | 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 OTP? 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 1…ynthetic Mesh Common/usual name: Surgical Mesh Classification Name: - Mesh, Surgical, Polymeric 21 CFR 878.3300, Class II Premarket Notification: Proxy Biomedical, Ltd., K051245 E. Device Description The proposed device is a sterile, single use device, consisting of a synthetic mesh assembly and needle h… | 2005 |
What descends from it? (7)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 12, 2018 | Class II | Z-1625-2018 | Device Design | Potential for Capio sutures to break and /or detach. |
| Feb 12, 2018 | Class II | Z-1624-2018 | Device Design | |
| May 10, 2011 | Not classified | Z-2931-2011 | Device Design | The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All OTP devicesOTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · OTP
2in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · OTP
71in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OTP
No recall names OTP since 2007.
Adverse event reports per year · OTP
26in 2025
MAUDE reports naming product code OTP, 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 | 4 | 90 | 0 | 1 |
| 2008 | 8 | 103 | 0 | 0 |
| 2009 | 6 | 21 | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 5 | 71 | 0 | 32 |
| 2012 | 2 | — | 0 | 494 |
| 2013 | 0 | — | 0 | 7,150 |
| 2014 | 0 | — | 0 | 778 |
| 2015 | 0 | — | 0 | 684 |
| 2016 | 0 | — | 0 | 415 |
| 2017 | 0 | — | 0 | 273 |
| 2018 | 0 | — | 0 | 392 |
| 2019 | 0 | — | 0 | 368 |
| 2020 | 0 | — | 0 | 175 |
| 2021 | 0 | — | 0 | 647 |
| 2022 | 0 | — | 0 | 114 |
| 2023 | 0 | — | 0 | 59 |
| 2024 | 0 | — | 0 | 35 |
| 2025 | 0 | — | 0 | 26 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Pinnacle™ Pelvic Floor Repair Kits are indicated for tissue reinforcement and
stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, 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/K071957 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071957: Pinnacle Pelvic Floor Repair Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071957
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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