510(k) · Cleared

Cleared

Ams Apogee Vault Suspension System

K040537510(k) TraditionalCleared Apr 22, 200451-day reviewClass III21 CFR 884.5980

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

American Medical Systems, Inc. · OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

Cleared on Apr 22, 2004 as substantially equivalent to K011251 (American Medical Systems, Inc., 2001) and 6 other predicates after a 51-day review. Its family tree reaches back 7 generations to 1993. 70 later devices descend from it.

Decided: Apr 22, 2004
Review: 51 days
Class: Class III
Product code: OTP
Recalls: None
Predicates: 7

Its longest line of descent runs back 7 generations to K931386 (1993). 20 ancestors in all, the oldest K922916 (1992). 70 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 7 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
6 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
5 generations backK972651 IN-SlingInfluence, Inc. · 1997
4 generations backK980482 Triangle SlingInfluence, Inc. · 1998
3 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
2 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
1 generation backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
This deviceK040537 Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004
Descendant · cites it directly · 30 of its ownK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
Descendant · cites it directly · 20 of its ownK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
Descendant · cites it directly · 17 of its ownK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
Descendant · 2 generations on · 13 of its ownK092207 Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009
Descendant · 2 generations on · 12 of its ownK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008

Showing 5 of 70 descendants. See all descendants

Descendants cleared per year

2005high 11 (2012) · low 0 (2019)2026

Most influential descendants

Showing 5 of 70 · See all

K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · cites it directly30descendants
K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008 · cites it directly20descendants
K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005 · cites it directly17descendants
K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009 · 2 generations on13descendants
K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc. · 2008 · 2 generations on12descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K931386	Hemashield Microvel/Woven Double Velour Fabric	Meadox Medicals, Div. Boston Scientific Corp.	1993	—
−6	K963611	Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft…	Vascutek, Ltd.	1996	1
−5	K972651	IN-Sling	Influence, Inc.	1997	—
−4	K980482	Triangle Sling	Influence, Inc.	1998	—
−3	K002721	Ams Triangle Silicone-Coated Sling and Surgical Mesh	American Medical Systems, Inc.	2000	—
−2	K010931	Ams Sacral Colpopexy Sling, Model 72403501	American Medical Systems, Inc.	2001	—
−1	K033636	Ams Large Pore Polypropylene Mesh	American Medical Systems, Inc.	2003	—
0 (this device)	K040537	Ams Apogee Vault Suspension System	American Medical Systems, Inc.	2004	—
+1	K050445	Ams Collagen Dermal Matrix	American Medical Systems, Inc.	2005	1
+1	K071512	Gynecare Prolift +M* Pelvic Floor Repair Systems	ETHICON, Inc.	2008	—
+1	K051485	Ams Pelvic Floor Repair System	American Medical Systems, Inc.	2005	—
+2	K092207	Restorelle Polypropylene Mesh	Mpathy Medical Devices, Inc.	2009	—
+2	K073219	WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal…	American Medical Systems, Inc.	2008	—

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	3	0
2007	1	0
2008	10	0
2009	7	0
2010	3	0
2011	5	0
2012	11	0
2013	5	0
2014	1	0
2015	2	0
2016	2	0
2017	1	0
2018	3	0
2021	1	0
2022	2	0
2023	3	0
2024	2	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K040537, 1993–2026Source: 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

Get a 510(k) Report

What was it cleared against? (7)

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
*	K011251	Sparc Sling System Summary page 1 …OTP Classification: Class I Manufacturing Location: American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343 Predicate Devices: AMS Sparc Sling System — K011251, K013355, K020663 AMS Monarg Sling System — K023516 AMS BioArc — K030123 AMS Large Pore Polypropylene Mesh — K033636 IVS Tunnelle…	American Medical Systems, Inc.	2001	—
*	K013355	Sparc Sling System Summary page 1 …ification: Class I Manufacturing Location: American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343 Predicate Devices: AMS Sparc Sling System — K011251, K013355, K020663 AMS Monarg Sling System — K023516 AMS BioArc — K030123 AMS Large Pore Polypropylene Mesh — K033636 IVS Tunneller — KO100…	American Medical Systems, Inc.	2001	—
*	K020663	Modification to Sparc Sling System Summary page 1 …: Class I Manufacturing Location: American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343 Predicate Devices: AMS Sparc Sling System — K011251, K013355, K020663 AMS Monarg Sling System — K023516 AMS BioArc — K030123 AMS Large Pore Polypropylene Mesh — K033636 IVS Tunneller — KO10035 Indic…	American Medical Systems, Inc.	2002	—
*	K023516	Monarc Sling System Summary page 1 …American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343 Predicate Devices: AMS Sparc Sling System — K011251, K013355, K020663 AMS Monarg Sling System — K023516 AMS BioArc — K030123 AMS Large Pore Polypropylene Mesh — K033636 IVS Tunneller — KO10035 Indications for Use: The Apogee™ Vault…	American Medical Systems, Inc.	2002	1
*	K030123	Bioarc SP Sling Kit Summary page 1 …tems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343 Predicate Devices: AMS Sparc Sling System — K011251, K013355, K020663 AMS Monarg Sling System — K023516 AMS BioArc — K030123 AMS Large Pore Polypropylene Mesh — K033636 IVS Tunneller — KO10035 Indications for Use: The Apogee™ Vault Suspension System is…	American Medical Systems, Inc.	2003	—
*	K033636	Ams Large Pore Polypropylene Mesh Summary page 1 …N 55343 Predicate Devices: AMS Sparc Sling System — K011251, K013355, K020663 AMS Monarg Sling System — K023516 AMS BioArc — K030123 AMS Large Pore Polypropylene Mesh — K033636 IVS Tunneller — KO10035 Indications for Use: The Apogee™ Vault Suspension System is intended for use in vaginal vault suspension…	American Medical Systems, Inc.	2003	—
*	K010035	Ivs Tunneller	United States Surgical, A Division of Tyco Healthc	2001	—

Also cleared against K011251: 12 other devices →

What descends from it? (70)

See all 70

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K050445	Ams Collagen Dermal Matrix	American Medical Systems, Inc.	2005	30
K071512	Gynecare Prolift +M* Pelvic Floor Repair Systems	ETHICON, Inc.	2008	20
K051485	Ams Pelvic Floor Repair System	American Medical Systems, Inc.	2005	17
K053371	Ams Male Transobturator Sling System	American Medical Systems, Inc.	2006	10
K083722	Ascend	Caldera Medical, Inc.	2009	7

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?

The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 10 months on median.
3 of the 20 ancestors have a recall of any class.
Of its descendants, K050445 (American Medical Systems, Inc., 2005) has gone furthest, with 30 descendants of its own.
12 other devices also cite its predicate K011251.

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.

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 Apogee™ Vault Suspension System is intended for use in vaginal vault suspension to treat pelvic organ 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/K040537 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040537: Ams Apogee Vault Suspension System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040537

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