510(k) · Cleared

Recalled · Class II · 2018

Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support System

K122459510(k) AbbreviatedCleared Dec 13, 2012122-day reviewClass III21 CFR 884.5980Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific Corporation · OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

Cleared on Dec 13, 2012 as substantially equivalent to K103426 (Boston Scientific Corp, 2011) after a 122-day review. Its family tree reaches back 13 generations to 1993. 2 later devices descend from it. It has been recalled 2 times.

Decided: Dec 13, 2012
Review: 122 days
Class: Class III
Product code: OTP
Recalls: 2
Predicates: 1

Its longest line of descent runs back 13 generations to K931386 (1993). 39 ancestors in all, the oldest K905655 (1990). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 13 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
9 generations between
3 generations backK081048 Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp · 2008 · Recalled
2 generations backK091131 Pelvic Floor Repair SystemBoston Scientific · 2009
1 generation backK103426 Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011
This deviceK122459 Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal…Boston Scientific Corporation · 2012
Descendant · cites it directly · 1 of its ownK172060 Capio SLIM Suture Capturing DeviceBoston Scientific Corporation · 2017 · Recalled
Descendant · 2 generations on · 0 of its ownK173527 Digitex Delivery DeviceColoplast A/S · 2018

Show all 13 generations

Root · 13 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
12 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
11 generations backK972651 IN-SlingInfluence, Inc. · 1997
10 generations backK980482 Triangle SlingInfluence, Inc. · 1998
9 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
8 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
7 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
6 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
5 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
4 generations backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
3 generations backK081048 Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp · 2008 · Recalled
2 generations backK091131 Pelvic Floor Repair SystemBoston Scientific · 2009
1 generation backK103426 Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011
This deviceK122459 Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal…Boston Scientific Corporation · 2012

Most influential descendants

Showing 2 of 2 · See all

K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation · 2017 · cites it directly1descendant
K173527Digitex Delivery DeviceColoplast A/S · 2018 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−13	K931386	Hemashield Microvel/Woven Double Velour Fabric	Meadox Medicals, Div. Boston Scientific Corp.	1993	—
−12	K963611	Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft…	Vascutek, Ltd.	1996	1
−11	K972651	IN-Sling	Influence, Inc.	1997	—
−10	K980482	Triangle Sling	Influence, Inc.	1998	—
−9	K002721	Ams Triangle Silicone-Coated Sling and Surgical Mesh	American Medical Systems, Inc.	2000	—
−8	K010931	Ams Sacral Colpopexy Sling, Model 72403501	American Medical Systems, Inc.	2001	—
−7	K033636	Ams Large Pore Polypropylene Mesh	American Medical Systems, Inc.	2003	—
−6	K040521	Modification to Ams Large Pore Polypropylene Mesh	American Medical Systems, Inc.	2004	—
−5	K040623	Ams Perigee System	American Medical Systems, Inc.	2004	—
−4	K071512	Gynecare Prolift +M* Pelvic Floor Repair Systems	ETHICON, Inc.	2008	—
−3	K081048	Pinnacle Pelvic Floor Repair Kit II	Boston Scientific Corp	2008	1
−2	K091131	Pelvic Floor Repair System	Boston Scientific	2009	—
−1	K103426	Lite Pelvic Floor Repair Kits	Boston Scientific Corp	2011	—
0 (this device)	K122459	Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support…	Boston Scientific Corporation	2012	—
+1	K172060	Capio SLIM Suture Capturing Device	Boston Scientific Corporation	2017	4
+2	K173527	Digitex Delivery Device	Coloplast A/S	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1992	1	0
1994	1	0
1996	2	0
1998	2	0
2000	1	0
2001	4	0
2002	5	0
2003	1	0
2004	3	0
2005	2	0
2006	1	0
2007	1	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0
2018	1	0

FIG. 1 — Lineage of K122459, 1993–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K103426	Lite Pelvic Floor Repair Kits Summary page 1 …~ OTP — Mesh, Surgical, Synthetic, Urogynecologic, for Pelvic Organ Prolapse, Transvaginally Placed 21 CFR 878.3300, Class 11 Premarket Notification: Boston Scientific, K103426 . Device Description The proposed devices were submitted for a leg assembly modification to the previously cleared LITE Pelvic…	Boston Scientific Corp	2011	—

Also cleared against K103426: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K172060	Capio SLIM Suture Capturing Device	Boston Scientific Corporation	2017	1

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-1623-2018	Device Design	Potential for Capio sutures to break and /or detach.
Feb 12, 2018	Class II	Z-1622-2018	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 19 years and passes through 8 companies; a new generation was cleared every 10 months on median.
7 of the 39 ancestors have a recall of any class.
Of its descendants, K172060 (Boston Scientific Corporation, 2017) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K103426.

How does its category compare?

All OTP devices

OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · OTP

2in 2012

2007high 8 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OTP

71in 2011

2007high 103 (2008) · low 21 (2009)2026

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

2007high 7,150 (2013) · low 0 (2008)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	MAUDE reports
2007	4	90	1
2008	8	103	0
2009	6	21	3
2010	0	—	3
2011	5	71	32
2012	2	—	494
2013	0	—	7,150
2014	0	—	778
2015	0	—	684
2016	0	—	415
2017	0	—	273
2018	0	—	392
2019	0	—	368
2020	0	—	175
2021	0	—	647
2022	0	—	114
2023	0	—	59
2024	0	—	35
2025	0	—	26
2026	0	—	—

What is it indicated for?

The Pinnacle LITE Pelvic Floor Repair Kit is indicated for tissue reinforcement in women with pelvic organ prolapse, for transvaginal repair of posterior vaginal vault prolapse.

The Uphold LITE Vaginal Support System is indicated for tissue reinforcement in women with pelvic organ prolapse, for the transvaginal repair of anterior and apical vaginal wall prolapse.

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/K122459 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122459: Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122459

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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