510(k) Report

510(k) · Cleared

Cleared

Ethicon Physiomesh, Flexible Composite Mesh

K093932510(k) TraditionalCleared Apr 9, 2010108-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

Ethicon GmbH · FTL Mesh, Surgical, Polymeric

Cleared on Apr 9, 2010 as substantially equivalent to K031925 (ETHICON, Inc., 2003) and 3 other predicates after a 108-day review. Its family tree reaches back 1 generation to 2003. 5 later devices descend from it.

Decided
Apr 9, 2010
Review
108 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K031925 (2003). 4 ancestors in all. 5 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2006: 1 other ancestor2004: 1 other ancestor2015: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant clearedK031925 · Proceed Trilaminate Surgical Mesh · ETHICON, Inc. · 2003 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 3 descendants K031925 · Proceed Trilaminate Surgical Mesh · ETHICON, Inc. · 2003 · recalled0
  1. Root · 1 generation backK031925 Proceed Trilaminate Surgical MeshETHICON, Inc. · 2003 · Recalled
  2. This deviceK093932 Ethicon Physiomesh, Flexible Composite MeshEthicon GmbH · 2010
  3. Descendant · cites it directly · 3 of its ownK152609 GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc. · 2015
  4. Descendant · 2 generations on · 1 of its ownK173333 GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018
  5. Descendant · 2 generations on · 0 of its ownK222919 GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. · 2022
  6. Descendant · 2 generations on · 0 of its ownK163576 GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc. · 2017
  7. Descendant · cites it directly · 0 of its ownK141560 Ethicon Physiomesh Open Flexible Composite Mesh DeviceETHICON, Inc. · 2014

Most influential descendants

Showing 5 of 5 · See all
  • K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc. · 2015 · cites it directly3descendants
  • K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018 · 2 generations on1descendant
  • K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. · 2022 · 2 generations on0descendants
  • K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc. · 2017 · 2 generations on0descendants
  • K141560Ethicon Physiomesh Open Flexible Composite Mesh DeviceETHICON, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K031925Proceed Trilaminate Surgical MeshETHICON, Inc.20031
0 (this device)K093932Ethicon Physiomesh, Flexible Composite MeshEthicon GmbH2010—
+1K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.2015—
+2K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.2018—
+2K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.2022—
+2K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.2017—
+1K141560Ethicon Physiomesh Open Flexible Composite Mesh DeviceETHICON, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201710
201810
202210
FIG. 1 — Lineage of K093932, 2003–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K031925Proceed Trilaminate Surgical Mesh
Summary page 1
…Phone: + 1.908.218.3323 FAX: +1.908.218.2595 4. Substantially Equivalent To: The ETHCON PHYSIOMESH3N is substantially equivalent to: PROCEED Mesh (K03 1925 & For Indications for Use and technological characteristics K0607 13) _______…
ETHICON, Inc.20031
*K060713Proceed Surgical Mesh
Summary page 1
…nt To: The ETHCON PHYSIOMESH3N is substantially equivalent to: PROCEED Mesh (K03 1925 & For Indications for Use and technological characteristics K0607 13) ________________________ ULTRAPRO Hernia System For technological characte…
ETHICON, Inc.20063
*K071249Ultrapro* Hernia System, Models Uhsl, Uhsm, Uhsov
Summary page 1
…stics K0607 13) ________________________ ULTRAPRO Hernia System For technological characteristics related to the (K6071249) poligelcaprone 25 Film ULTRAPRO Mesh (K(033337) For technological characterist…
ETHICON, Inc.2007—
*K033337Ultrapro Mesh
Summary page 1
…PRO Hernia System For technological characteristics related to the (K6071249) poligelcaprone 25 Film ULTRAPRO Mesh (K(033337) For technological characteristics related to the mesh _______________________Imaterials pol…
ETHICON, Inc.2004—

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153
K141560Ethicon Physiomesh Open Flexible Composite Mesh DeviceETHICON, Inc.20140

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?

  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K152609 (W. L. Gore & Associates, Inc., 2015) has gone furthest, with 3 descendants of its own.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · FTL

6in 2025

2007: 202008: 232009: 152010: 182011: 152012: 122013: 82014: 112015: 122016: 32017: 62018: 122019: 42020: 52021: 22022: 62023: 42024: 22025: 62026 (partial year): 2
2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007: 92 days median2008: 114 days median2009: 97 days median2010: 132 days median2011: 90 days median2012: 213 days median2013: 90 days median2014: 70 days median2015: 121 days median2016: 186 days median2017: 132 days median2018: 105 days median2019: 99 days median2020: 138 days median2022: 195 days median2023: 29 days median2025: 30 days median
2007high 213 (2012) · low 29 (2023)2026

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

Recalls per year · FTL

1in 2020

2007: 22008: 12009: 12010: 122011: 82012: 22013: 12014: 32017: 12018: 12020: 1
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

2007: 1,7372008: 1,5692009: 1,9062010: 2,1752011: 3,6082012: 14,7002013: 26,5192014: 2,6832015: 2,5262016: 2,4172017: 3,9472018: 11,8932019: 21,7242020: 18,8192021: 16,2842022: 11,4392023: 8,0252024: 8,5652025: 3,487
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007209221,737
20082311411,569
2009159711,906
201018132122,175
2011159083,608
201212213214,700
2013890126,519
2014117032,683
20151212102,526
2016318602,417
2017613213,947
201812105111,893
2019499021,724
20205138118,819
20212—016,284
20226195011,439
202342908,025
20242—08,565
202563003,487
20262—0—

What is it indicated for?

ETHICON PHYSIOMESH™ may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Indications for use as stated in the FDA summary.

Recent decisions in FTL

The FTL category page

  • K260474Liora Monofilament ScaffoldTELA Bio, Inc. · 2026
  • K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026
  • K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production · 2025
  • K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025
  • K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc. · 2025

https://510kreport.com/device/K093932 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093932: Ethicon Physiomesh, Flexible Composite Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093932

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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