510(k) · Cleared
Recalled · Class II · 2018Pinnacle Pelvic Floor Repair Kit II
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 Aug 22, 2008 as substantially equivalent to K071957 (Boston Scientific Corp, 2007) and 1 other predicate after a 130-day review. Its family tree reaches back 10 generations to 1993. 6 later devices descend from it. It has been recalled once.
- Decided
- Aug 22, 2008
- Review
- 130 days
- Class
- Class III
- Product code
- OTP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 10 generations to K931386 (1993). 27 ancestors in all, the oldest K922916 (1992). 6 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 6 generations between
- 3 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 2 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 1 generation backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
- This deviceK081048 Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp · 2008
- 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
- Descendant · 4 generations on · 0 of its ownK173527 Digitex Delivery DeviceColoplast A/S · 2018
Show all 10 generations
- Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 9 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 8 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 7 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 6 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 5 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 4 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 3 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 2 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 1 generation backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
- This deviceK081048 Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp · 2008
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- 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
- K173527Digitex Delivery DeviceColoplast A/S · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −9 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −8 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −7 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −6 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −5 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −4 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −3 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −2 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −1 | K071512 | Gynecare Prolift +M* Pelvic Floor Repair Systems | ETHICON, Inc. | 2008 | — |
| 0 (this device) | K081048 | Pinnacle Pelvic Floor Repair Kit II | Boston Scientific Corp | 2008 | — |
| +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 |
| +4 | K173527 | Digitex Delivery Device | Coloplast A/S | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K071957 | Pinnacle Pelvic Floor Repair KitsSummary page 1…or Repair Kt Common/usual name: Surgical Mesh Classification Name: Gflf— Mesh, Surgical, Polymeric 21 CFR 878.3300, Class 1l Premarket Notification: Boston Scientific, K071957 and Tradename: Prolift Pelvic Floor Repair Systems Common/usual name: Surgical Mesh Classification Name: OTP- Mesh, Surgical,… | 2007 |
| * | K071512 | Gynecare Prolift +M* Pelvic Floor Repair Systems Cleared while this submission was under review Summary page 1…Floor Repair Systems Common/usual name: Surgical Mesh Classification Name: OTP- Mesh, Surgical, Polymeric 21 CFR 878.3300, Class II Premarket Notification: Gynecare, K071512 E. Device Description The proposed device is a sterile, single use device, consisting of a synthetic mesh assembly and needle ho… | 2008 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 12, 2018 | Class II | Z-1626-2018 | Device Design | Potential for Capio sutures to break and /or detach. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 4 of the 27 ancestors have a recall of any class.
- Of its descendants, K091131 (Boston Scientific, 2009) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K071957.
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. 2008, 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 proposed Pinnacle Pelvic Floor Repair Kit is 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/K081048 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081048: Pinnacle Pelvic Floor Repair Kit II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081048
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