510(k) · Cleared

Recalled · 2012

Modification to: Minimesh Polypropylene Mesh

K053361510(k) SpecialCleared Feb 6, 200666-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

Mpathy Medical Devices, Ltd. · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Cleared on Feb 6, 2006 as substantially equivalent to K041632 (Mpathy Medical Devices, Ltd., 2004) after a 66-day review. Its family tree reaches back 3 generations to 1994. 16 later devices descend from it. It has been recalled once.

Decided: Feb 6, 2006
Review: 66 days
Class: Class II
Product code: OTO
Recalls: 1
Predicates: 1

Its longest line of descent runs back 3 generations to K945377 (1994). 9 ancestors in all, the oldest K905655 (1990). 16 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK945377 Trelex Natural (R) MeshMeadox Medicals, Div. Boston Scientific Corp. · 1994
2 generations backK020110 Modification to Trelex Mesh Surgical MeshBoston Scientific · 2002
1 generation backK041632 Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 2004 · Recalled
This deviceK053361 Modification to: Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 2006
Descendant · cites it directly · 13 of its ownK092207 Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009
Descendant · cites it directly · 9 of its ownK090739 Bard Sacrocolpopexy GraftC.R. Bard, Inc. · 2009
Descendant · 2 generations on · 8 of its ownK101722 Alyte Y-Mesh GraftC.R. Bard, Inc. · 2011
Descendant · 2 generations on · 6 of its ownK112322 Restorelle Polypropylene Y MeshColoplast A/S · 2012
Descendant · 2 generations on · 4 of its ownK103426 Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2009high 4 (2012) · low 0 (2016)2026

Most influential descendants

Showing 5 of 16 · See all

K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009 · cites it directly13descendants
K090739Bard Sacrocolpopexy GraftC.R. Bard, Inc. · 2009 · cites it directly9descendants
K101722Alyte Y-Mesh GraftC.R. Bard, Inc. · 2011 · 2 generations on8descendants
K112322Restorelle Polypropylene Y MeshColoplast A/S · 2012 · 2 generations on6descendants
K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K945377	Trelex Natural (R) Mesh	Meadox Medicals, Div. Boston Scientific Corp.	1994	—
−2	K020110	Modification to Trelex Mesh Surgical Mesh	Boston Scientific	2002	—
−1	K041632	Minimesh Polypropylene Mesh	Mpathy Medical Devices, Ltd.	2004	1
0 (this device)	K053361	Modification to: Minimesh Polypropylene Mesh	Mpathy Medical Devices, Ltd.	2006	—
+1	K092207	Restorelle Polypropylene Mesh	Mpathy Medical Devices, Inc.	2009	—
+1	K090739	Bard Sacrocolpopexy Graft	C.R. Bard, Inc.	2009	—
+2	K101722	Alyte Y-Mesh Graft	C.R. Bard, Inc.	2011	—
+2	K112322	Restorelle Polypropylene Y Mesh	Coloplast A/S	2012	—
+2	K103426	Lite Pelvic Floor Repair Kits	Boston Scientific Corp	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1998	2	0
2000	1	0
2001	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	2	0
2010	1	0
2011	2	0
2012	4	0
2013	2	0
2014	1	0
2015	1	0
2017	1	0
2018	2	0

FIG. 1 — Lineage of K053361, 1994–2018Source: 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 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? (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
*	K041632	Minimesh Polypropylene Mesh Summary page 1 …Ltd.) January 30, 2006 Polymeric Surgical Mesh (Product Code (T() is a Class Il device per 21 CFR 878.3300 OTP Polymeric Surgical Mesh Minimesh® polypropylene mesh K041632 Minimesh® polypropylene mesh Minimesh® is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded…	Mpathy Medical Devices, Ltd.	2004	1

Also cleared against K041632: 5 other devices →

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K092207	Restorelle Polypropylene Mesh	Mpathy Medical Devices, Inc.	2009	13
K090739	Bard Sacrocolpopexy Graft	C.R. Bard, Inc.	2009	9
K103568	Restorelle Polypropylene Mesh; Restorelle Polypropylene Mesh	Coloplast A/S	2010	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 2, 2012	Not classified	Z-1481-2012	Error in labeling	Coloplast is conducting a field correction based on the conclusion that two lots of Restorelle DirectFix Posterior mesh were mislabeled. The incorrect size was printed on the patient label. Specifically the patient label depicts the size…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
2 of the 9 ancestors have a recall of any class.
Of its descendants, K092207 (Mpathy Medical Devices, Inc., 2009) has gone furthest, with 13 descendants of its own.
5 other devices also cite its predicate K041632.

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?

MINIMESH® polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, uterological 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.

https://510kreport.com/device/K053361 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053361: Modification to: Minimesh 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/K053361

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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