510(k) · Cleared

Recalled · 2007

Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic Floor Repair

K013718510(k) TraditionalCleared Jan 8, 200261-day reviewClass II21 CFR 878.3300Recalls 1

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

Gynecare, A Div. of Ethicon, Inc. · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Cleared on Jan 8, 2002 after a 61-day review. The FDA summary names its predicate without a number. 153 later devices descend from it. It has been recalled once.

Decided: Jan 8, 2002
Review: 61 days
Class: Class II
Product code: OTO
Recalls: 1
Predicates: 0

153 later devices descend from it, 6 citing it directly.

This deviceK013718 Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic…Gynecare, A Div. of Ethicon, Inc. · 2002
Descendant · cites it directly · 79 of its ownK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
Descendant · 2 generations on · 74 of its ownK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
Descendant · 2 generations on · 70 of its ownK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
Descendant · 2 generations on · 70 of its ownK040537 Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004
Descendant · cites it directly · 70 of its ownK033376 Ugytex MeshSofradim Production · 2004

Showing 5 of 153 descendants. See all descendants

Descendants cleared per year

2003high 19 (2008) · low 1 (2003)2026

Most influential descendants

Showing 5 of 153 · See all

K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003 · cites it directly79descendants
K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004 · 2 generations on74descendants
K040623Ams Perigee SystemAmerican Medical Systems, Inc. · 2004 · 2 generations on70descendants
K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004 · 2 generations on70descendants
K033376Ugytex MeshSofradim Production · 2004 · cites it directly70descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K013718	Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh…	Gynecare, A Div. of Ethicon, Inc.	2002	—
+1	K033636	Ams Large Pore Polypropylene Mesh	American Medical Systems, Inc.	2003	—
+2	K040521	Modification to Ams Large Pore Polypropylene Mesh	American Medical Systems, Inc.	2004	—
+2	K040623	Ams Perigee System	American Medical Systems, Inc.	2004	—
+2	K040537	Ams Apogee Vault Suspension System	American Medical Systems, Inc.	2004	—
+1	K033376	Ugytex Mesh	Sofradim Production	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	6	0
2005	5	0
2006	7	0
2007	4	0
2008	19	0
2009	10	0
2010	8	0
2011	12	0
2012	17	0
2013	10	0
2014	10	0
2015	5	0
2016	3	0
2017	2	0
2018	6	0
2019	2	0
2020	1	0
2021	2	0
2022	7	0
2023	3	0
2024	3	0
2025	6	0
2026	4	0

FIG. 1 — Lineage of K013718, 2002–2026Source: 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 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

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What was it cleared against? (3)

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	Recalls
*	—	PROLENE Soft (Polypropylene) Mesh Named without a submission number	—
*	—	PROLENE* (Polypropylene) Mesh Named without a submission number	—
*	—	MERSILENE* Mesh Named without a submission number	—

What descends from it? (153)

See all 153

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

Number	Device	Applicant	Decided	Descendants
K033636	Ams Large Pore Polypropylene Mesh	American Medical Systems, Inc.	2003	79
K033376	Ugytex Mesh	Sofradim Production	2004	70
K041632	Minimesh Polypropylene Mesh	Mpathy Medical Devices, Ltd.	2004	27
K071512	Gynecare Prolift +M* Pelvic Floor Repair Systems	ETHICON, Inc.	2008	20
K053414	Mentor Novasilk Mesh	Mentor Corp.	2005	8
K082216	TBD Ethicon Mesh	ETHICON, Inc.	2008	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 20, 2007	Not classified	Z-0795-2007	Other	The pre-printed outer box incorrectly identifies the product as GYNECARE PROLIFT Total Pelvic Floor System (Product Code PFRT01). The contents of the box actually contain GYNECARE PROLIFT Anterior Pelvic Floor System (Product Code PFRA01)

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K033636 (American Medical Systems, Inc., 2003) has gone furthest, with 79 descendants of its own.

How does its category compare?

All OTO devices

OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OTO

1in 2017

2007high 7 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OTO

95in 2013

2007high 101 (2012) · low 95 (2013)2026

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

2007high 2,272 (2013) · low 0 (2007)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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	1	—	7
2012	7	101	160
2013	4	95	2,272
2014	1	—	267
2015	2	—	448
2016	0	—	156
2017	1	—	75
2018	0	—	145
2019	0	—	347
2020	0	—	153
2021	0	—	292
2022	0	—	112
2023	0	—	101
2024	0	—	113
2025	0	—	79
2026	0	—	—

What is it indicated for?

GYNEMESH PROLENE Soft (Polypropylene) Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical 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/K013718 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013718: Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic Floor Repair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013718

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026