510(k) · Cleared

Cleared

Dexon 'S' Polyglycolic Acid Mesh

K830889510(k) TraditionalCleared May 9, 198349-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 9, 1983 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 307 later devices descend from it.

Decided: May 9, 1983
Review: 49 days
Class: Class II
Product code: FTM
Recalls: None
Predicates: 0

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

This deviceK830889 Dexon 'S' Polyglycolic Acid MeshDavis & Geck, Inc. · 1983
Descendant · cites it directly · 284 of its ownK980431 SurgisisCook Biotech, Inc. · 1998
Descendant · 2 generations on · 204 of its ownK992159 Surgisis SlingCook Biotech, Inc. · 1999
Descendant · 2 generations on · 173 of its ownK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
Descendant · 3 generations on · 102 of its ownK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
Descendant · 2 generations on · 93 of its ownK034039 Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004

Showing 5 of 307 descendants. See all descendants

Descendants cleared per year

1996high 20 (2017) · low 0 (1997)2026

Most influential descendants

Showing 5 of 307 · See all

K980431SurgisisCook Biotech, Inc. · 1998 · cites it directly284descendants
K992159Surgisis SlingCook Biotech, Inc. · 1999 · 2 generations on204descendants
K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · 2 generations on173descendants
K020049Fortaflex Surgical MeshOrganogenesis, Inc. · 2002 · 3 generations on102descendants
K034039Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004 · 2 generations on93descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K830889	Dexon 'S' Polyglycolic Acid Mesh	Davis & Geck, Inc.	1983	—
+1	K980431	Surgisis	Cook Biotech, Inc.	1998	—
+2	K992159	Surgisis Sling	Cook Biotech, Inc.	1999	—
+2	K001738	Depuy Restore Orthobiologic Soft Tissue Implant	DePuy Orthopaedics, Inc.	2000	—
+3	K020049	Fortaflex Surgical Mesh	Organogenesis, Inc.	2002	—
+2	K034039	Sis Plastic Surgery Matrix	Cook Biotech, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	2	0
1999	1	0
2000	1	0
2002	9	0
2003	5	0
2004	6	0
2005	12	0
2006	13	0
2007	14	0
2008	19	0
2009	15	0
2010	11	0
2011	16	0
2012	13	0
2013	13	0
2014	17	0
2015	10	0
2016	17	0
2017	20	0
2018	12	0
2019	10	0
2020	4	0
2021	8	0
2022	9	0
2023	9	0
2024	13	0
2025	16	0
2026	11	0

FIG. 1 — Lineage of K830889, 1983–2026Source: 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? (307)

See all 307

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

Number	Device	Applicant	Decided	Descendants
K980431	Surgisis	Cook Biotech, Inc.	1998	284
K040868	Sepramesh IP Bioresorbable Barrier - Permanent Mesh	Genzyme Corp.	2004	34
K053066	Sepramesh IP Bioresorbable Coating/Permanent Mesh	Genzyme Corporation	2005	17
K963619	Gore-Tex Soft Tissue Patch,Mycromesha Biomaterial,Dualmesh Biomaterial,Dualmesh…	W. L. Gore & Associates, Inc.	1996	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, K980431 (Cook Biotech, Inc., 1998) has gone furthest, with 284 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/K830889 · printed Nov 3, 2026

Cite this page

510(k) Report. “K830889: Dexon 'S' Polyglycolic Acid Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K830889

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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