510(k) Report

510(k) · Cleared

Cleared

Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh

K001122510(k) TraditionalCleared May 23, 200046-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, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on May 23, 2000 after a 46-day review. The FDA summary names its predicate without a number. 152 later devices descend from it.

Decided
May 23, 2000
Review
46 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
0

152 later devices descend from it, 13 citing it directly.

Descendants, by year cleared 2014: 7 descendants cleared2017: 6 descendants cleared2006: 10 descendants cleared2004: 5 descendants cleared2009: 10 descendants cleared2010: 9 descendants cleared2008: 16 descendants cleared2003: 1 descendant cleared2007: 2 descendants cleared2005: 3 descendants cleared2012: 13 descendants cleared2015: 8 descendants cleared2011: 10 descendants cleared2018: 9 descendants cleared2025: 6 descendants cleared2022: 5 descendants cleared2013: 11 descendants cleared2026: 5 descendants cleared2019: 2 descendants cleared2016: 4 descendants cleared2021: 1 descendant cleared2024: 3 descendants cleared2023: 3 descendants cleared2020: 3 descendants cleared200020052010201520202025
  1. This deviceK001122 Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical MeshETHICON, Inc. · 2000
  2. Descendant · cites it directly · 79 of its ownK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
  3. Descendant · 2 generations on · 74 of its ownK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
  4. Descendant · 2 generations on · 70 of its ownK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
  5. Descendant · 2 generations on · 70 of its ownK040537 Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004
  6. Descendant · 3 generations on · 30 of its ownK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled

Showing 5 of 152 descendants. See all descendants

Descendants cleared per year

2003: 12004: 52005: 32006: 102007: 22008: 162009: 102010: 92011: 102012: 132013: 112014: 72015: 82016: 42017: 62018: 92019: 22020: 32021: 12022: 52023: 32024: 32025: 62026: 5
2003high 16 (2008) · low 1 (2003)2026

Most influential descendants

Showing 5 of 152 · See all
  • K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003 · cites it directly79descendants
  • K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004 · 2 generations on74descendants
  • K040623Ams Perigee SystemAmerican Medical Systems, Inc. · 2004 · 2 generations on70descendants
  • K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004 · 2 generations on70descendants
  • K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · 3 generations on30descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001122Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical MeshETHICON, Inc.2000—
+1K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.2003—
+2K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.2004—
+2K040623Ams Perigee SystemAmerican Medical Systems, Inc.2004—
+2K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc.2004—
+3K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.20051

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200450
200530
2006100
200720
2008160
2009100
201090
2011100
2012130
2013110
201470
201580
201640
201760
201890
201920
202030
202110
202250
202330
202430
202560
202650
FIG. 1 — Lineage of K001122, 2000–2026Source: 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? (2)

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
*—PROLENE* (Polypropylene) Mesh
Named without a submission number
—
*—MERSILENE* Mesh
Named without a submission number
—

What descends from it? (152)

See all 152

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

NumberDeviceApplicantDecidedDescendants
K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200379
K041632Minimesh Polypropylene MeshMpathy Medical Devices, Ltd.200427
K043081Gore Polypropylene Hernia MeshW. L. Gore & Associates, Inc.200426
K081069Gore Infinit MeshW. L. Gore & Associates, Inc.200821
K053424PopmeshCaldera Medical, Inc.20068
K053158Optilene Mesh LPAesculap, Inc.20065
K092224Tigr Surgical Mesh , Model WK-6Novus Scientific Pte, Ltd.20103
K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093
K142091Parietene Macroporous MeshSofradim Production20142
K163152PROLENE Soft Polypropylene MeshETHICON, Inc.20171

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, K033636 (American Medical Systems, Inc., 2003) has gone furthest, with 79 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?

The PROLENE, Soft (Polypropylene) Mesh is indicated for the repair of hernia or other fascial defects 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

  • P240035/S004ETHIZIA™ Hemostatic PatchETHICON, Inc. · 2026
  • 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/K001122 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001122: Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001122

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026