510(k) · Cleared

Cleared

Modification to Trelex Mesh Surgical Mesh

K020110510(k) AbbreviatedCleared Apr 3, 200282-day reviewClass II21 CFR 878.3300

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

Boston Scientific · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Cleared on Apr 3, 2002 as substantially equivalent to K974098 (ETHICON, Inc., 1998) and 3 other predicates after an 82-day review. Its family tree reaches back 1 generation to 1994. 38 later devices descend from it.

Decided: Apr 3, 2002
Review: 82 days
Class: Class II
Product code: OTN
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K945377 (1994). 4 ancestors in all. 38 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK945377 Trelex Natural (R) MeshMeadox Medicals, Div. Boston Scientific Corp. · 1994
This deviceK020110 Modification to Trelex Mesh Surgical MeshBoston Scientific · 2002
Descendant · cites it directly · 27 of its ownK041632 Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 2004 · Recalled
Descendant · 2 generations on · 16 of its ownK053361 Modification to: Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 2006 · Recalled
Descendant · 2 generations on · 13 of its ownK092207 Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009
Descendant · 3 generations on · 9 of its ownK090739 Bard Sacrocolpopexy GraftC.R. Bard, Inc. · 2009
Descendant · 4 generations on · 8 of its ownK101722 Alyte Y-Mesh GraftC.R. Bard, Inc. · 2011

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2003high 6 (2012) · low 0 (2005)2026

Most influential descendants

Showing 5 of 38 · See all

K041632Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 2004 · cites it directly27descendants
K053361Modification to: Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 2006 · 2 generations on16descendants
K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009 · 2 generations on13descendants
K090739Bard Sacrocolpopexy GraftC.R. Bard, Inc. · 2009 · 3 generations on9descendants
K101722Alyte Y-Mesh GraftC.R. Bard, Inc. · 2011 · 4 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945377	Trelex Natural (R) Mesh	Meadox Medicals, Div. Boston Scientific Corp.	1994	—
0 (this device)	K020110	Modification to Trelex Mesh Surgical Mesh	Boston Scientific	2002	—
+1	K041632	Minimesh Polypropylene Mesh	Mpathy Medical Devices, Ltd.	2004	1
+2	K053361	Modification to: Minimesh Polypropylene Mesh	Mpathy Medical Devices, Ltd.	2006	1
+2	K092207	Restorelle Polypropylene Mesh	Mpathy Medical Devices, Inc.	2009	—
+3	K090739	Bard Sacrocolpopexy Graft	C.R. Bard, Inc.	2009	—
+4	K101722	Alyte Y-Mesh Graft	C.R. Bard, Inc.	2011	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	2	0
2006	2	0
2007	1	0
2008	3	0
2009	4	0
2010	3	0
2011	2	0
2012	6	0
2013	2	0
2014	2	0
2015	2	0
2016	1	0
2017	2	0
2018	2	0
2021	1	0
2022	1	0
2023	1	0

FIG. 1 — Lineage of K020110, 1994–2023Source: 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 OTN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OTN device

#1 K231549 Advantage Ultra System, Advantage Fit Ultra…score 6.8 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K974098	Pubouurethral Sling Summary page 1 …urgical Mesh 4. Suspend Sling Common/usual name: Surgical Mesh Classification Name: OTN- Mesh, Surgical, Polymeric - 21 CFR 878.3300, Class I Premarket Notification: 1. K974098 (TVT) 2. K945377 (BSC) 3. K010533 (INJECTX, INC) 4, K980483 (MENTOR) E. Device Description The proposed sling is a sterile, sing…	ETHICON, Inc.	1998	—
*	K945377	Trelex Natural (R) Mesh Summary page 1 …uspend Sling Common/usual name: Surgical Mesh Classification Name: OTN- Mesh, Surgical, Polymeric - 21 CFR 878.3300, Class I Premarket Notification: 1. K974098 (TVT) 2. K945377 (BSC) 3. K010533 (INJECTX, INC) 4, K980483 (MENTOR) E. Device Description The proposed sling is a sterile, single use device, co…	Meadox Medicals, Div. Boston Scientific Corp.	1994	—
*	K010533	Biosling - Bioabsorbable Polymer Sling & Surgical Mesh Summary page 1 …mon/usual name: Surgical Mesh Classification Name: OTN- Mesh, Surgical, Polymeric - 21 CFR 878.3300, Class I Premarket Notification: 1. K974098 (TVT) 2. K945377 (BSC) 3. K010533 (INJECTX, INC) 4, K980483 (MENTOR) E. Device Description The proposed sling is a sterile, single use device, consisting of a syn…	Injectx, Inc.	2001	—
*	K980483	Mentor Suspend Sling Summary page 1 …esh Classification Name: OTN- Mesh, Surgical, Polymeric - 21 CFR 878.3300, Class I Premarket Notification: 1. K974098 (TVT) 2. K945377 (BSC) 3. K010533 (INJECTX, INC) 4, K980483 (MENTOR) E. Device Description The proposed sling is a sterile, single use device, consisting of a synthetic mesh sling assembly…	Mentor Corp.	1998	—

Also cleared against K974098: 11 other devices →

What descends from it? (38)

See all 38

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

Number	Device	Applicant	Decided	Descendants
K041632	Minimesh Polypropylene Mesh	Mpathy Medical Devices, Ltd.	2004	27
K040787	Modification to Surgical Mesh Polymeric	Boston Scientific	2004	4
K023898	Gyne Ideas Minitape RP Device	Gyne Ideas, Ltd.	2003	4
K121754	Blue Sui Sling	Boston Scientific Corp	2012	3
K211223	Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System	Boston Scientific Corporation	2021	1
K172565	Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device…	Boston Scientific Corporation	2017	0

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?

None of the 4 ancestors has a recall.
Of its descendants, K041632 (Mpathy Medical Devices, Ltd., 2004) has gone furthest, with 27 descendants of its own.
11 other devices also cite its predicate K974098.

How does its category compare?

All OTN devices

OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OTN

1in 2023

2007high 5 (2010) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OTN

89in 2021

2007high 100 (2008) · low 25 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OTN

1in 2014

2007high 1 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OTN

458in 2025

2007high 19,084 (2013) · low 0 (2007)2025

MAUDE reports naming product code OTN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	0
2008	3	100	0	0
2009	2	—	0	0
2010	5	25	0	1
2011	4	56	0	25
2012	1	—	0	874
2013	5	86	0	19,084
2014	1	—	1	2,063
2015	0	—	0	3,904
2016	0	—	0	1,902
2017	1	—	0	676
2018	0	—	0	737
2019	1	—	0	2,457
2020	1	—	0	1,003
2021	3	89	0	2,606
2022	2	—	0	809
2023	1	—	0	1,076
2024	0	—	0	822
2025	0	—	0	458
2026	1	—	0	—

What is it indicated for?

The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

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/K020110 · printed Nov 5, 2026

Cite this page

510(k) Report. “K020110: Modification to Trelex Mesh Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020110

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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