510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Parietex Composite Mono PM Mesh

K081126510(k) TraditionalCleared Aug 13, 2008114-day reviewClass II21 CFR 878.3300Recalls 1

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

Sofradim Production · FTL Mesh, Surgical, Polymeric

Cleared on Aug 13, 2008 as substantially equivalent to K040998 (Sofradim Production, 2004) after a 114-day review. Its family tree reaches back 3 generations to 1999. 15 later devices descend from it. It has been recalled once.

Decided
Aug 13, 2008
Review
114 days
Class
Class II
Product code
FTL
Recalls
1
Predicates
1

Its longest line of descent runs back 3 generations to K991400 (1999). 5 ancestors in all. 15 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2002: 1 other ancestor2010: 1 descendant cleared2014: 3 descendants cleared2013: 2 descendants cleared2009: 1 descendant cleared2022: 2 descendants cleared2015: 2 descendants cleared2024: 1 descendant cleared2018: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK991400 · Parietene Polypropylene Mesh · Sofradim Production · 1999×2: 2 generations cleared close together, K033376 (2004), K040998 (2004) 1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K040998 · Modification to Parietex Composite (Pco) Mesh · Sofradim Production · 2004K033376 · Ugytex Mesh · Sofradim Production · 2004K991400 · Parietene Polypropylene Mesh · Sofradim Production · 19990+5
  1. Root · 3 generations backK991400 Parietene Polypropylene MeshSofradim Production · 1999
  2. 2 generations backK033376 Ugytex MeshSofradim Production · 2004
  3. 1 generation backK040998 Modification to Parietex Composite (Pco) MeshSofradim Production · 2004
  4. This deviceK081126 Parietex Composite Mono PM MeshSofradim Production · 2008
  5. Descendant · cites it directly · 14 of its ownK090858 Parietex Monofilament Polyester MeshSofradim Production · 2009
  6. Descendant · cites it directly · 10 of its ownK131969 Symbotex (TM) Composite MeshSofradim Production · 2013
  7. Descendant · cites it directly · 6 of its ownK101519 Parietex Plug and PatchSofradim Production · 2010
  8. Descendant · cites it directly · 5 of its ownK142908 Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight…Sofradim Production · 2014 · Recalled
  9. Descendant · 2 generations on · 5 of its ownK142900 Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester…Sofradim Production · 2014

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12013: 22014: 32015: 22018: 12022: 22024: 12025: 12026: 1
2009high 3 (2014) · low 0 (2011)2026

Most influential descendants

Showing 5 of 15 · See all
  • K090858Parietex Monofilament Polyester MeshSofradim Production · 2009 · cites it directly14descendants
  • K131969Symbotex (TM) Composite MeshSofradim Production · 2013 · cites it directly10descendants
  • K101519Parietex Plug and PatchSofradim Production · 2010 · cites it directly6descendants
  • K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex…Sofradim Production · 2014 · cites it directly5descendants
  • K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug…Sofradim Production · 2014 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K991400Parietene Polypropylene MeshSofradim Production1999—
−2K033376Ugytex MeshSofradim Production2004—
−1K040998Modification to Parietex Composite (Pco) MeshSofradim Production2004—
0 (this device)K081126Parietex Composite Mono PM MeshSofradim Production2008—
+1K090858Parietex Monofilament Polyester MeshSofradim Production2009—
+1K131969Symbotex (TM) Composite MeshSofradim Production2013—
+1K101519Parietex Plug and PatchSofradim Production2010—
+1K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh)…Sofradim Production20141
+2K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh)…Sofradim Production2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201320
201430
201520
201810
202220
202410
202510
202610
FIG. 1 — Lineage of K081126, 1999–2026Source: 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? (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
*K040998Modification to Parietex Composite (Pco) Mesh
Summary page 1
…COMMON/USUAL NAME: Surgical Mesh CLASSIFICATION NAME: Mesh. Surgical, Polymeric PREDICATE DEVICE: PARIETEX TM COMPOSITE (PCO) Mesh (KO040998) DEVICE DESCRIPTION: PARIETEX TM COMPOSITE Mono PM Mesh is made from a monofilament polye…
Sofradim Production2004—

Also cleared against K040998: 12 other devices →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K090858Parietex Monofilament Polyester MeshSofradim Production200914
K131969Symbotex (TM) Composite MeshSofradim Production201310
K101519Parietex Plug and PatchSofradim Production20106
K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex…Sofradim Production20145

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 5, 2018Class IIZ-0461-2019Unknown/Undetermined by firmThe firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair technique. In these reports, product…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 4.3 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K090858 (Sofradim Production, 2009) has gone furthest, with 14 descendants of its own.
  • 12 other devices also cite its predicate K040998.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?

The PARIETEX TM COMPOSITE Mono PM Mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The non-absorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.

Indications for use as stated in the FDA summary.

Also cleared against K040998

12 other devices cite the same predicate.

  • K173796Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh…Sofradim Production · 20182 recalls
  • K130428CovameshBiomup S.A. · 2013
  • K131969Symbotex (TM) Composite MeshSofradim Production · 2013
  • K120506Parietex Composite Ventral PatchSofradim Production · 2012
  • K111584Xylos Macro-Porous Surgical MeshXylos Corporation · 2011
  • K110663Pairetex Optimized Composite Mesh (Pco-FX Refrences)Sofradim Production · 2011

More from Sofradim Production

43 FDA decisions under this applicant name. See the company

  • K262443Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)Sofradim Production · 2026
  • K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026
  • K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production · 2025
  • K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production · 2025
  • K233661Transorb™ Self-Gripping Resorbable MeshSofradim Production · 2024

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/K081126 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081126: Parietex Composite Mono PM Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081126

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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