510(k) · Cleared

Cleared

Vicryl (Polyglactin 910/Mersilene Compoisite Mesh

K851086510(k) TraditionalCleared May 21, 198564-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

Cleared on May 21, 1985 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.

Decided: May 21, 1985
Review: 64 days
Class: Class II
Product code: FTM
Recalls: None
Predicates: 0

24 later devices descend from it, 4 citing it directly.

This deviceK851086 Vicryl (Polyglactin 910/Mersilene Compoisite MeshETHICON, Inc. · 1985
Descendant · cites it directly · 17 of its ownK070894 Tephaflex Surgical MeshTepha, Inc. · 2007
Descendant · 2 generations on · 4 of its ownK143380 Phasix ST MeshC.R. Bard, Inc. · 2015
Descendant · 2 generations on · 3 of its ownK142818 Phasix MeshC. R. Bard · 2015
Descendant · 2 generations on · 3 of its ownK140533 Galaflex MeshTepha, Inc. · 2014
Descendant · cites it directly · 3 of its ownK092224 Tigr Surgical Mesh , Model WK-6Novus Scientific Pte, Ltd. · 2010 · Recalled

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2005high 4 (2018) · low 0 (2006)2026

Most influential descendants

Showing 5 of 24 · See all

K070894Tephaflex Surgical MeshTepha, Inc. · 2007 · cites it directly17descendants
K143380Phasix ST MeshC.R. Bard, Inc. · 2015 · 2 generations on4descendants
K142818Phasix MeshC. R. Bard · 2015 · 2 generations on3descendants
K140533Galaflex MeshTepha, Inc. · 2014 · 2 generations on3descendants
K092224Tigr Surgical Mesh , Model WK-6Novus Scientific Pte, Ltd. · 2010 · cites it directly3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K851086	Vicryl (Polyglactin 910/Mersilene Compoisite Mesh	ETHICON, Inc.	1985	—
+1	K070894	Tephaflex Surgical Mesh	Tepha, Inc.	2007	—
+2	K143380	Phasix ST Mesh	C.R. Bard, Inc.	2015	—
+2	K142818	Phasix Mesh	C. R. Bard	2015	—
+2	K140533	Galaflex Mesh	Tepha, Inc.	2014	—
+1	K092224	Tigr Surgical Mesh , Model WK-6	Novus Scientific Pte, Ltd.	2010	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	2	0
2010	2	0
2011	1	0
2012	2	0
2014	1	0
2015	2	0
2016	2	0
2017	2	0
2018	4	0
2020	1	0
2021	1	0
2022	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K851086, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FTM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K070894	Tephaflex Surgical Mesh	Tepha, Inc.	2007	17
K092224	Tigr Surgical Mesh , Model WK-6	Novus Scientific Pte, Ltd.	2010	3
K063154	Facial Reconstructive Mesh (FRM)	Evera Medical, Inc.	2007	0
K050969	Inclose Surgical Mesh System	Anulex Technologies, Inc.	2005	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?

Of its descendants, K070894 (Tepha, Inc., 2007) has gone furthest, with 17 descendants of its own.

How does its category compare?

All FTM devices

FTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTM

1in 2025

2007high 9 (2007) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTM

29in 2024

2007high 316 (2015) · low 29 (2024)2026

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

Recalls per year · FTM

1in 2023

2007high 21 (2018) · low 0 (2009)2026

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

Adverse event reports per year · FTM

232in 2025

2007high 3,351 (2013) · low 60 (2007)2025

MAUDE reports naming product code FTM, 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	9	104	7	60
2008	9	86	1	141
2009	7	86	0	476
2010	2	—	1	197
2011	6	100	8	288
2012	4	66	0	467
2013	4	123	0	3,351
2014	8	153	0	1,093
2015	4	316	0	977
2016	7	88	0	509
2017	9	147	0	529
2018	2	—	21	357
2019	6	107	4	418
2020	4	59	1	457
2021	4	61	1	369
2022	0	—	0	375
2023	2	—	1	485
2024	3	29	0	383
2025	1	—	0	232
2026	1	—	0	—

https://510kreport.com/device/K851086 · printed Nov 4, 2026

Cite this page

510(k) Report. “K851086: Vicryl (Polyglactin 910/Mersilene Compoisite Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K851086

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026