510(k) · Cleared

Cleared

Gore Polypropylene Hernia Mesh

K043081510(k) TraditionalCleared Dec 22, 200444-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

W. L. Gore & Associates, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Dec 22, 2004 as substantially equivalent to K001122 (ETHICON, Inc., 2000) and 1 other predicate after a 44-day review. Its family tree reaches back 1 generation to 2000. 26 later devices descend from it.

Decided: Dec 22, 2004
Review: 44 days
Class: Class II
Product code: FTL
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K001122 (2000). 2 ancestors in all. 26 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK001122 Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical MeshETHICON, Inc. · 2000
This deviceK043081 Gore Polypropylene Hernia MeshW. L. Gore & Associates, Inc. · 2004
Descendant · cites it directly · 25 of its ownK052864 Tyrx Surgical Mesh, Model SMPC-0501Tyrx Pharma, Inc. · 2005
Descendant · 2 generations on · 24 of its ownK053656 Tyrx Antimicrobial MeshTyrx Pharma, Inc. · 2006
Descendant · 3 generations on · 17 of its ownK063091 Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · Recalled
Descendant · 4 generations on · 14 of its ownK130943 Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013
Descendant · 4 generations on · 6 of its ownK131007 Aigis RX N Medium; Aigis RX N LargeTyrx, Inc. · 2013

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2005high 3 (2013) · low 0 (2007)2026

Most influential descendants

Showing 5 of 26 · See all

K052864Tyrx Surgical Mesh, Model SMPC-0501Tyrx Pharma, Inc. · 2005 · cites it directly25descendants
K053656Tyrx Antimicrobial MeshTyrx Pharma, Inc. · 2006 · 2 generations on24descendants
K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · 3 generations on17descendants
K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013 · 4 generations on14descendants
K131007Aigis RX N Medium; Aigis RX N LargeTyrx, Inc. · 2013 · 4 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001122	Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh	ETHICON, Inc.	2000	—
0 (this device)	K043081	Gore Polypropylene Hernia Mesh	W. L. Gore & Associates, Inc.	2004	—
+1	K052864	Tyrx Surgical Mesh, Model SMPC-0501	Tyrx Pharma, Inc.	2005	—
+2	K053656	Tyrx Antimicrobial Mesh	Tyrx Pharma, Inc.	2006	—
+3	K063091	Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601	Tyrx Pharma, Inc.	2008	3
+4	K130943	Aigis RX R PM/ Aigis RX R Icd	Tyrx, Inc.	2013	—
+4	K131007	Aigis RX N Medium; Aigis RX N Large	Tyrx, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2008	1	0
2010	1	0
2012	1	0
2013	3	0
2014	3	0
2015	3	0
2016	1	0
2017	1	0
2018	3	0
2019	1	0
2020	3	0
2022	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K043081, 2000–2026Source: 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 FTL? 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 FTL device

#1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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? (3)

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
*	K001122	Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh Summary page 2 …® Mesh (Davol, Inc. Cranston, RI) - Pre-amendment Device * Prolene TM Soft Polypropylene Mesh (Ethicon Inc, Somerville, NJ) - K001122 * Atrium Lite ' Mesh (Atrium Medical Corp, Hudson, New Hampshire) - K002093 e[~Co…	ETHICON, Inc.	2000	—
*	K002093	Atrium Lite Mesh Summary page 2 …con Inc, Somerville, NJ) - K001122 * Atrium Lite ' Mesh (Atrium Medical Corp, Hudson, New Hampshire) - K002093 e[~Confidential 29 510(k)…	Atrium Medical Corp.	2000	—
*	—	Bard® Mesh Named without a submission number			—

Also cleared against K001122: 12 other devices →

What descends from it? (26)

See all 26

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K052864	Tyrx Surgical Mesh, Model SMPC-0501	Tyrx Pharma, Inc.	2005	25

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 2 ancestors has a recall.
Of its descendants, K052864 (Tyrx Pharma, Inc., 2005) has gone furthest, with 25 descendants of its own.
12 other devices also cite its predicate K001122.

How does its category compare?

All FTL devices

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

FDA decisions per year · FTL

6in 2025

2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007high 213 (2012) · low 29 (2023)2026

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

Recalls per year · FTL

1in 2020

2007high 12 (2010) · low 0 (2015)2026

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

Adverse event reports per year · FTL

3,487in 2025

2007high 26,519 (2013) · low 1,569 (2008)2025

MAUDE reports naming product code FTL, 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	20	92	2	1,737
2008	23	114	1	1,569
2009	15	97	1	1,906
2010	18	132	12	2,175
2011	15	90	8	3,608
2012	12	213	2	14,700
2013	8	90	1	26,519
2014	11	70	3	2,683
2015	12	121	0	2,526
2016	3	186	0	2,417
2017	6	132	1	3,947
2018	12	105	1	11,893
2019	4	99	0	21,724
2020	5	138	1	18,819
2021	2	—	0	16,284
2022	6	195	0	11,439
2023	4	29	0	8,025
2024	2	—	0	8,565
2025	6	30	0	3,487
2026	2	—	0	—

What is it indicated for?

The GORE POLYPROPYLENE Hernia Mesh is a sterile, non-absorbable, knitted polypropylene monofilament mesh intended for the reconstruction of hernias and soft tissue deficiencies. Examples of applications where the GORE® POLYPROPYLENE HERNIA MESH may be used include, but are not limited to:

Hernia repair (inguinal, femoral, umbilical, abdominal, incisional, epigastric, and intermuscular).

Muscle flap reinforcement

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043081 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043081: Gore Polypropylene Hernia Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043081

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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