510(k) Report

510(k) · Cleared

Cleared

Restorelle Polypropylene Mesh

K092207510(k) SpecialCleared Aug 4, 200913-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

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

Cleared on Aug 4, 2009 as substantially equivalent to K041632 (Mpathy Medical Devices, Ltd., 2004) and 3 other predicates after a 13-day review. Its family tree reaches back 10 generations to 1993. 13 later devices descend from it.

Decided
Aug 4, 2009
Review
13 days
Class
Class III
Product code
OTP
Recalls
None
Predicates
4

Its longest line of descent runs back 10 generations to K931386 (1993). 32 ancestors in all, the oldest K905655 (1990). 13 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2004: 3 other ancestors2002: 5 other ancestors2000: 1 other ancestor1990: 1 other ancestor2003: 1 other ancestor2001: 4 other ancestors1998: 2 other ancestors1996: 2 other ancestors1994: 1 other ancestor1992: 1 other ancestor2012: 4 descendants cleared2011: 1 descendant cleared2010: 1 descendant cleared2013: 2 descendants cleared2017: 1 descendant cleared2015: 1 descendant cleared2014: 1 descendant cleared2018: 2 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) ×3: 3 generations cleared close together, K033636 (2003), K040521 (2004), K040623 (2004) K071512 · Gynecare Prolift +M* Pelvic Floor Repair Systems · ETHICON, Inc. · 20081990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 6 other ancestors3 generations back: 12 other ancestors4 generations back: 1 other ancestor5 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants K071512 · Gynecare Prolift +M* Pelvic Floor Repair Systems · ETHICON, Inc. · 2008K040623 · Ams Perigee System · American Medical Systems, Inc. · 2004K040521 · Modification to Ams Large Pore Polypropylene Mesh · American Medical Systems, Inc. · 2004K033636 · Ams Large Pore Polypropylene Mesh · American Medical Systems, Inc. · 2003K010931 · 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. · 1993−10−50
  1. Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
  2. 6 generations between
  3. 3 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
  4. 2 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
  5. 1 generation backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
  6. This deviceK092207 Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009
  7. Descendant · cites it directly · 6 of its ownK112322 Restorelle Polypropylene Y MeshColoplast A/S · 2012
  8. Descendant · cites it directly · 4 of its ownK103426 Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011
  9. Descendant · 2 generations on · 2 of its ownK123914 Restorelle Y ContourColoplast A/S · 2013
  10. Descendant · 2 generations on · 2 of its ownK122459 Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal…Boston Scientific Corporation · 2012 · Recalled
  11. Descendant · 3 generations on · 1 of its ownK172060 Capio SLIM Suture Capturing DeviceBoston Scientific Corporation · 2017 · Recalled
Show all 10 generations
  1. Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
  2. 9 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
  3. 8 generations backK972651 IN-SlingInfluence, Inc. · 1997
  4. 7 generations backK980482 Triangle SlingInfluence, Inc. · 1998
  5. 6 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
  6. 5 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
  7. 4 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
  8. 3 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
  9. 2 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
  10. 1 generation backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
  11. This deviceK092207 Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12012: 42013: 22014: 12015: 12017: 12018: 2
2010high 4 (2012) · low 0 (2016)2026

Most influential descendants

Showing 5 of 13 · See all
  • K112322Restorelle Polypropylene Y MeshColoplast A/S · 2012 · cites it directly6descendants
  • K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011 · cites it directly4descendants
  • K123914Restorelle Y ContourColoplast A/S · 2013 · 2 generations on2descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K931386Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp.1993—
−9K963611Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft…Vascutek, Ltd.19961
−8K972651IN-SlingInfluence, Inc.1997—
−7K980482Triangle SlingInfluence, Inc.1998—
−6K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc.2000—
−5K010931Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc.2001—
−4K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.2003—
−3K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.2004—
−2K040623Ams Perigee SystemAmerican Medical Systems, Inc.2004—
−1K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc.2008—
0 (this device)K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.2009—
+1K112322Restorelle Polypropylene Y MeshColoplast A/S2012—
+1K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp2011—
+2K123914Restorelle Y ContourColoplast A/S2013—
+2K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support…Boston Scientific Corporation20122
+3K172060Capio SLIM Suture Capturing DeviceBoston Scientific Corporation20174

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199210
199410
199620
199820
200010
200140
200250
200310
200430
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201240
201320
201410
201510
201710
201820
FIG. 1 — Lineage of K092207, 1993–2018Source: 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? (4)

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
*K041632Minimesh Polypropylene Mesh
Summary page 1
…oduct Code OTP, is a Class |l device per 21 CFR 878.3300 S)(6] COMMON NAME Polymeric Surgical Mesh PROPRIETARY Restorelle™ polypropylene mesh NAME PREDICATE DEVICE « K041632 & K053361 - Minimesh (Mpathy Medical _ Ltd) » K010931 — Straight In sacral colpopexy mesh - (American Medical Systems) « KO07151…
Mpathy Medical Devices, Ltd.20041
*K053361Modification to: Minimesh Polypropylene Mesh
Summary page 1
…OTP, is a Class |l device per 21 CFR 878.3300 S)(6] COMMON NAME Polymeric Surgical Mesh PROPRIETARY Restorelle™ polypropylene mesh NAME PREDICATE DEVICE « K041632 & K053361 - Minimesh (Mpathy Medical _ Ltd) » K010931 — Straight In sacral colpopexy mesh - (American Medical Systems) « KO071512 - Gyneca…
Mpathy Medical Devices, Ltd.20061
*K010931Ams Sacral Colpopexy Sling, Model 72403501
Summary page 1
…0 S)(6] COMMON NAME Polymeric Surgical Mesh PROPRIETARY Restorelle™ polypropylene mesh NAME PREDICATE DEVICE « K041632 & K053361 - Minimesh (Mpathy Medical _ Ltd) » K010931 — Straight In sacral colpopexy mesh - (American Medical Systems) « KO071512 - Gynecare Prolift (Ethicon) DEVICE Restorelle™ is a…
American Medical Systems, Inc.2001—
*K071512Gynecare Prolift +M* Pelvic Floor Repair Systems
Summary page 1
…pylene mesh NAME PREDICATE DEVICE « K041632 & K053361 - Minimesh (Mpathy Medical _ Ltd) » K010931 — Straight In sacral colpopexy mesh - (American Medical Systems) « KO071512 - Gynecare Prolift (Ethicon) DEVICE Restorelle™ is a non-absorbable polypropylene mesh DESCRIPTION constructed from knitted mono…
ETHICON, Inc.2008—

Also cleared against K041632: 5 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K112322Restorelle Polypropylene Y MeshColoplast A/S20126
K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp20114
K113205Artisyn Y-Shaped MeshETHICON, Inc.20120
K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S20100

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 16 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
  • 5 of the 32 ancestors have a recall of any class.
  • Of its descendants, K112322 (Coloplast A/S, 2012) has gone furthest, with 6 descendants of its own.
  • 5 other devices also cite its predicate K041632.

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. 2009, this device’s year, is highlighted.

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?

RESTORELLE™ polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

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 K041632

5 other devices cite the same predicate.

  • K103568Restorelle Polypropylene Mesh; Restorelle Polypropylene MeshColoplast A/S · 20101 recall
  • K090271Hydrocoat MeshPromethean Surgical Devices, Inc. · 2010
  • K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc. · 2007
  • K060018Trulene MeshSutures India Pvt., Ltd. · 2006
  • K053361Modification to: Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 20061 recall

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/K092207 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092207: Restorelle 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/K092207

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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