510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Proceed Surgical Mesh

K060713510(k) TraditionalCleared May 25, 200669-day reviewClass II21 CFR 878.3300Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

ETHICON, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on May 25, 2006 after a 69-day review. The FDA summary names its predicate without a number. 9 later devices descend from it. It has been recalled 3 times.

Decided
May 25, 2006
Review
69 days
Class
Class II
Product code
FTL
Recalls
3
Predicates
0

9 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2017: 2 descendants cleared2010: 2 descendants cleared2011: 1 descendant cleared2015: 1 descendant cleared2014: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared20052010201520202025
  1. This deviceK060713 Proceed Surgical MeshETHICON, Inc. · 2006
  2. Descendant · cites it directly · 5 of its ownK093932 Ethicon Physiomesh, Flexible Composite MeshEthicon GmbH · 2010
  3. Descendant · 2 generations on · 3 of its ownK152609 GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc. · 2015
  4. Descendant · 3 generations on · 1 of its ownK173333 GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018
  5. Descendant · cites it directly · 1 of its ownK093123 Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation · 2010
  6. Descendant · 3 generations on · 0 of its ownK222919 GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. · 2022

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2010: 22011: 12014: 12015: 12017: 22018: 12022: 1
2010high 2 (2010) · low 0 (2012)2026

Most influential descendants

Showing 5 of 9 · See all
  • K093932Ethicon Physiomesh, Flexible Composite MeshEthicon GmbH · 2010 · cites it directly5descendants
  • K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc. · 2015 · 2 generations on3descendants
  • K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018 · 3 generations on1descendant
  • K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation · 2010 · cites it directly1descendant
  • K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K060713Proceed Surgical MeshETHICON, Inc.2006—
+1K093932Ethicon Physiomesh, Flexible Composite MeshEthicon GmbH2010—
+2K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.2015—
+3K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.2018—
+1K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation2010—
+3K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201110
201410
201510
201720
201810
202210
FIG. 1 — Lineage of K060713, 2006–2022Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*—PROCEED Trilaminate Surgical Mesh
Named without a submission number
—

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K093932Ethicon Physiomesh, Flexible Composite MeshEthicon GmbH20105
K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101
K163212Parietene DS Composite MeshSofradim Production20170

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 23, 2020Class IIZ-0533-2021Under Investigation by firmThe firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.
Feb 19, 2014Class IIZ-1329-2014Under Investigation by firmThe possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.
Oct 18, 2010Not classifiedZ-0903-2011Nonconforming Material/ComponentThere is a potential for delamination in one lot of Proceed surgical mesh.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K093932 (Ethicon GmbH, 2010) has gone furthest, with 5 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.

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?

PROCEED Surgical Mesh 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.

More from ETHICON, Inc.

654 FDA decisions under this applicant name. See the company

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  • N12159/S129SURGICELTM POWDER Absorbable Hemostatic PowderETHICON, Inc. · 2026
  • P240035/S002ETHIZIA Hemostatic PatchETHICON, Inc. · 2026
  • P880047/S070GYNECARE INTERCEED™ Absorbable Adhesion BarrierETHICON, Inc. · 2026
  • K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc. · 2026

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/K060713 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060713: Proceed Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060713

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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