510(k) · Cleared

Cleared

Mentor Novasilk Mesh

K053414510(k) TraditionalCleared Dec 27, 200520-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

Mentor Corp. · OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

Cleared on Dec 27, 2005 as substantially equivalent to K013718 (Gynecare, A Div. of Ethicon, Inc., 2002) after a 20-day review. Its family tree reaches back 1 generation to 2002. 8 later devices descend from it.

Decided: Dec 27, 2005
Review: 20 days
Class: Class III
Product code: OTP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K013718 (2002). 8 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK013718 Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic…Gynecare, A Div. of Ethicon, Inc. · 2002 · Recalled
This deviceK053414 Mentor Novasilk MeshMentor Corp. · 2005
Descendant · cites it directly · 4 of its ownK103426 Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011
Descendant · 2 generations on · 2 of its ownK122459 Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal…Boston Scientific Corporation · 2012 · Recalled
Descendant · 3 generations on · 1 of its ownK172060 Capio SLIM Suture Capturing DeviceBoston Scientific Corporation · 2017 · Recalled
Descendant · cites it directly · 1 of its ownK083499 Exair Anterior and Posterior Prolapse Repair SystemsColoplast A/S · 2009
Descendant · 4 generations on · 0 of its ownK173527 Digitex Delivery DeviceColoplast A/S · 2018

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2009high 3 (2012) · low 0 (2010)2026

Most influential descendants

Showing 5 of 8 · See all

K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011 · cites it directly4descendants
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
K083499Exair Anterior and Posterior Prolapse Repair SystemsColoplast A/S · 2009 · cites it directly1descendant
K173527Digitex Delivery DeviceColoplast A/S · 2018 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K013718	Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh…	Gynecare, A Div. of Ethicon, Inc.	2002	1
0 (this device)	K053414	Mentor Novasilk Mesh	Mentor Corp.	2005	—
+1	K103426	Lite Pelvic Floor Repair Kits	Boston Scientific Corp	2011	—
+2	K122459	Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support…	Boston Scientific Corporation	2012	2
+3	K172060	Capio SLIM Suture Capturing Device	Boston Scientific Corporation	2017	4
+1	K083499	Exair Anterior and Posterior Prolapse Repair Systems	Coloplast A/S	2009	—
+4	K173527	Digitex Delivery Device	Coloplast A/S	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2011	2	0
2012	3	0
2017	1	0
2018	1	0

FIG. 1 — Lineage of K053414, 2002–2018Source: 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 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? (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
*	K013718	Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic…	Gynecare, A Div. of Ethicon, Inc.	2002	1
†	K050148	Mentor Aris Trans-Obturator Tape and Surgical Kit	Mentor Corporation	2005	—

Also cleared against K013718: 5 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K103426	Lite Pelvic Floor Repair Kits	Boston Scientific Corp	2011	4
K083499	Exair Anterior and Posterior Prolapse Repair Systems	Coloplast A/S	2009	1
K122968	Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015	Coloplast Corp.	2012	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?

Its one ancestor has a recall.
Of its descendants, K103426 (Boston Scientific Corp, 2011) has gone furthest, with 4 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

2007high 8 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OTP

71in 2011

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	4	90	1
2008	8	103	0
2009	6	21	3
2010	0	—	3
2011	5	71	32
2012	2	—	494
2013	0	—	7,150
2014	0	—	778
2015	0	—	684
2016	0	—	415
2017	0	—	273
2018	0	—	392
2019	0	—	368
2020	0	—	175
2021	0	—	647
2022	0	—	114
2023	0	—	59
2024	0	—	35
2025	0	—	26
2026	0	—	—

What is it indicated for?

The Mentor NovaSilk 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.

https://510kreport.com/device/K053414 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053414: Mentor Novasilk Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053414

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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