510(k) Report

510(k) · Cleared

Cleared

Ams Large Pore Polypropylene Mesh

K033636510(k) TraditionalCleared Dec 31, 200342-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 Dec 31, 2003 as substantially equivalent to K013718 (Gynecare, A Div. of Ethicon, Inc., 2002) and 2 other predicates after a 42-day review. Its family tree reaches back 6 generations to 1993. 79 later devices descend from it.

Decided
Dec 31, 2003
Review
42 days
Class
Class III
Product code
OTP
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K931386 (1993). 12 ancestors in all, the oldest K922916 (1992). 79 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor1996: 2 other ancestors1992: 1 other ancestor2009: 8 descendants cleared2004: 3 descendants cleared2006: 4 descendants cleared2012: 12 descendants cleared2005: 2 descendants cleared2008: 11 descendants cleared2011: 6 descendants cleared2007: 1 descendant cleared2018: 3 descendants cleared2013: 6 descendants cleared2010: 3 descendants cleared2016: 2 descendants cleared2015: 2 descendants cleared2021: 1 descendant cleared2014: 1 descendant cleared2024: 2 descendants cleared2022: 2 descendants cleared2023: 3 descendants cleared2017: 1 descendant cleared2025: 3 descendants cleared2026: 3 descendants clearedK931386 · Hemashield Microvel/Woven Double Velour Fabric · Meadox Medicals, Div. Boston Scientific Corp. · 1993K963611 · Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch · Vascutek, Ltd. · 1996 · recalledK972651 · IN-Sling · Influence, Inc. · 1997K980482 · Triangle Sling · Influence, Inc. · 1998×2: 2 generations cleared close together, K002721 (2000), K010931 (2001) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors3 generations back: 3 other ancestors5 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 8 descendants3 generations forward: 20 descendants4 generations forward: 17 descendants5 generations forward: 12 descendants6 generations forward: 8 descendants7 generations forward: 7 descendants8 generations forward: 2 descendants K010931 · Ams Sacral Colpopexy Sling, Model 72403501 · American Medical Systems, Inc. · 2001K002721 · Ams Triangle Silicone-Coated Sling and Surgical Mesh · American Medical Systems, Inc. · 2000K980482 · Triangle Sling · Influence, Inc. · 1998K972651 · IN-Sling · Influence, Inc. · 1997K963611 · Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch · Vascutek, Ltd. · 1996 · recalledK931386 · Hemashield Microvel/Woven Double Velour Fabric · Meadox Medicals, Div. Boston Scientific Corp. · 1993−50+5
  1. Root · 6 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
  2. 5 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
  3. 4 generations backK972651 IN-SlingInfluence, Inc. · 1997
  4. 3 generations backK980482 Triangle SlingInfluence, Inc. · 1998
  5. 2 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
  6. 1 generation backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
  7. This deviceK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
  8. Descendant · cites it directly · 74 of its ownK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
  9. Descendant · cites it directly · 70 of its ownK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
  10. Descendant · cites it directly · 70 of its ownK040537 Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004
  11. Descendant · 2 generations on · 30 of its ownK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
  12. Descendant · 2 generations on · 20 of its ownK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008

Showing 5 of 79 descendants. See all descendants

Descendants cleared per year

2004: 32005: 22006: 42007: 12008: 112009: 82010: 32011: 62012: 122013: 62014: 12015: 22016: 22017: 12018: 32021: 12022: 22023: 32024: 22025: 32026: 3
2004high 12 (2012) · low 0 (2019)2026

Most influential descendants

Showing 5 of 79 · See all
  • K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004 · cites it directly74descendants
  • K040623Ams Perigee SystemAmerican Medical Systems, Inc. · 2004 · cites it directly70descendants
  • K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004 · cites it directly70descendants
  • K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · 2 generations on30descendants
  • K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008 · 2 generations on20descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K931386Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp.1993—
−5K963611Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft…Vascutek, Ltd.19961
−4K972651IN-SlingInfluence, Inc.1997—
−3K980482Triangle SlingInfluence, Inc.1998—
−2K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc.2000—
−1K010931Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc.2001—
0 (this device)K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.2003—
+1K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.2004—
+1K040623Ams Perigee SystemAmerican Medical Systems, Inc.2004—
+1K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc.2004—
+2K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.20051
+2K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199620
199810
200010
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200430
200520
200640
200710
2008110
200980
201030
201160
2012120
201360
201410
201520
201620
201710
201830
202110
202220
202330
202420
202530
202630
FIG. 1 — Lineage of K033636, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K013718Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic…
Summary page 1
…Classification: Class I Manufacturing Location: American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343 Predicate Devices: Gynemesh Prolene Soft Mesh — K013718 " Ethicon Prolene Soft Mesh - K001122 AMS Sacral Colpopexy Sling — K010931 Indications for Use: The AMS Large Pore Polypropylene…
Gynecare, A Div. of Ethicon, Inc.20021
*K001122Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh
Summary page 1
…Location: American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343 Predicate Devices: Gynemesh Prolene Soft Mesh — K013718 " Ethicon Prolene Soft Mesh - K001122 AMS Sacral Colpopexy Sling — K010931 Indications for Use: The AMS Large Pore Polypropylene Mesh is indicated for tissue reinforc…
ETHICON, Inc.2000—
*K010931Ams Sacral Colpopexy Sling, Model 72403501
Summary page 1
…Inc. 10700 Bren Rd. West Minnetonka, MN 55343 Predicate Devices: Gynemesh Prolene Soft Mesh — K013718 " Ethicon Prolene Soft Mesh - K001122 AMS Sacral Colpopexy Sling — K010931 Indications for Use: The AMS Large Pore Polypropylene Mesh is indicated for tissue reinforcement and long-lasting stabilization…
American Medical Systems, Inc.2001—

Also cleared against K013718: 5 other devices →

What descends from it? (79)

See all 79

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

NumberDeviceApplicantDecidedDescendants
K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200474
K040623Ams Perigee SystemAmerican Medical Systems, Inc.200470
K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc.200470
K090739Bard Sacrocolpopexy GraftC.R. Bard, Inc.20099
K060329Endofast Reliant SystemEndogun Medical Systems20062

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 10 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
  • 2 of the 12 ancestors have a recall of any class.
  • Of its descendants, K040521 (American Medical Systems, Inc., 2004) has gone furthest, with 74 descendants of its own.
  • 5 other devices also cite its predicate K013718.

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

2007: 42008: 82009: 62011: 52012: 2
2007high 8 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OTP

71in 2011

2007: 90 days median2008: 103 days median2009: 21 days median2011: 71 days median
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

2007: 12009: 32010: 32011: 322012: 4942013: 7,1502014: 7782015: 6842016: 4152017: 2732018: 3922019: 3682020: 1752021: 6472022: 1142023: 592024: 352025: 26
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200749001
2008810300
200962103
20100—03
2011571032
20122—0494
20130—07,150
20140—0778
20150—0684
20160—0415
20170—0273
20180—0392
20190—0368
20200—0175
20210—0647
20220—0114
20230—059
20240—035
20250—026
20260—0—

What is it indicated for?

The AMS Large Pore Polypropylene Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in 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.

Also cleared against K013718

5 other devices cite the same predicate.

  • K082216TBD Ethicon MeshETHICON, Inc. · 2008
  • K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
  • K053414Mentor Novasilk MeshMentor Corp. · 2005
  • K041632Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 20041 recall
  • K033376Ugytex MeshSofradim Production · 2004

More from American Medical Systems, Inc.

75 FDA decisions under this applicant name. See the company

  • K132655Retroarc Retropubic Sling SystemAmerican Medical Systems, Inc. · 2013
  • K112842Ams Elevate PCAmerican Medical Systems, Inc. · 2011
  • K100807Miniarc Precise Single-Incision Sling System Model: 720181, 720191American Medical Systems, Inc. · 2010
  • K092735Greenlight XPS Laser SystemAmerican Medical Systems, Inc. · 20091 recall
  • K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2009

Recent decisions in OTP

The OTP category page

  • K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation · 20122 recalls
  • K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems · 2012
  • K112842Ams Elevate PCAmerican Medical Systems, Inc. · 2011
  • K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011
  • K112386Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp. · 2011

https://510kreport.com/device/K033636 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033636: Ams Large Pore Polypropylene Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033636

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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