510(k) Report

510(k) · Cleared

Cleared

Parietex Optimized Composite Mesh (Pco-Osx References)

K110816510(k) SpecialCleared Apr 19, 201126-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

Sofradim Production · FTL Mesh, Surgical, Polymeric

Cleared on Apr 19, 2011 as substantially equivalent to K002699 (Medical Device Consultants, Inc., 2001) and 2 other predicates after a 26-day review. Its family tree reaches back 4 generations to 1999. 14 later devices descend from it.

Decided
Apr 19, 2011
Review
26 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K991400 (1999). 7 ancestors in all. 14 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2002: 1 other ancestor2012: 1 descendant cleared2014: 3 descendants cleared2018: 2 descendants cleared2013: 2 descendants cleared2022: 2 descendants cleared2015: 1 descendant cleared2024: 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) K050187 · Parietex Composite Pco-OS and Pco-OB Meshes · Sofradim Production · 20051995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K050187 · Parietex Composite Pco-OS and Pco-OB Meshes · Sofradim Production · 2005K040998 · Modification to Parietex Composite (Pco) Mesh · Sofradim Production · 2004K033376 · Ugytex Mesh · Sofradim Production · 2004K991400 · Parietene Polypropylene Mesh · Sofradim Production · 19990+5
  1. Root · 4 generations backK991400 Parietene Polypropylene MeshSofradim Production · 1999
  2. 3 generations backK033376 Ugytex MeshSofradim Production · 2004
  3. 2 generations backK040998 Modification to Parietex Composite (Pco) MeshSofradim Production · 2004
  4. 1 generation backK050187 Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production · 2005
  5. This deviceK110816 Parietex Optimized Composite Mesh (Pco-Osx References)Sofradim Production · 2011
  6. Descendant · cites it directly · 10 of its ownK131969 Symbotex (TM) Composite MeshSofradim Production · 2013
  7. Descendant · 2 generations on · 5 of its ownK142908 Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight…Sofradim Production · 2014 · Recalled
  8. Descendant · cites it directly · 4 of its ownK173796 Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D…Sofradim Production · 2018 · Recalled
  9. Descendant · 3 generations on · 4 of its ownK150091 Versatex Monofilament MeshSofradim Production · 2015 · Recalled
  10. Descendant · 2 generations on · 3 of its ownK220586 Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh…Sofradim Production · 2022

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2012: 12013: 22014: 32015: 12018: 22022: 22024: 12025: 12026: 1
2012high 3 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 14 · See all
  • K131969Symbotex (TM) Composite MeshSofradim Production · 2013 · cites it directly10descendants
  • K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex…Sofradim Production · 2014 · 2 generations on5descendants
  • K173796Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh)…Sofradim Production · 2018 · cites it directly4descendants
  • K150091Versatex Monofilament MeshSofradim Production · 2015 · 3 generations on4descendants
  • K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…Sofradim Production · 2022 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K991400Parietene Polypropylene MeshSofradim Production1999—
−3K033376Ugytex MeshSofradim Production2004—
−2K040998Modification to Parietex Composite (Pco) MeshSofradim Production2004—
−1K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production2005—
0 (this device)K110816Parietex Optimized Composite Mesh (Pco-Osx References)Sofradim Production2011—
+1K131969Symbotex (TM) Composite MeshSofradim Production2013—
+2K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh)…Sofradim Production20141
+1K173796Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical…Sofradim Production20182
+3K150091Versatex Monofilament MeshSofradim Production20152
+2K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex…Sofradim Production2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201320
201430
201510
201820
202220
202410
202510
202610
FIG. 1 — Lineage of K110816, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K002699Parietex Composite (Pco) Mesh
Summary page 1
…Regulation: 21 CFR 878.3300 Product Code: FTL Legally marketed devices to which equivalence is claimed: PARIETEX TM Composite Mesh (K002699, K040998 and K050187) Reason for 510(k) submission: The proposed PARIETEX TM Optimized Composite M…
Medical Device Consultants, Inc.2001—
*K040998Modification to Parietex Composite (Pco) Mesh
Summary page 1
…ion: 21 CFR 878.3300 Product Code: FTL Legally marketed devices to which equivalence is claimed: PARIETEX TM Composite Mesh (K002699, K040998 and K050187) Reason for 510(k) submission: The proposed PARIETEX TM Optimized Composite Mesh (PCO-…
Sofradim Production2004—
*K050187Parietex Composite Pco-OS and Pco-OB Meshes
Summary page 1
…oduct Code: FTL Legally marketed devices to which equivalence is claimed: PARIETEX TM Composite Mesh (K002699, K040998 and K050187) Reason for 510(k) submission: The proposed PARIETEX TM Optimized Composite Mesh (PCO- OSX referen…
Sofradim Production2005—

Also cleared against K002699: 7 other devices →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K131969Symbotex (TM) Composite MeshSofradim Production201310
K173796Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh)…Sofradim Production20184
K141560Ethicon Physiomesh Open Flexible Composite Mesh DeviceETHICON, Inc.20140
K120025Surgimesh XB - SkirtedAspide Medical20120

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?

  • The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 4.5 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K131969 (Sofradim Production, 2013) has gone furthest, with 10 descendants of its own.
  • 7 other devices also cite its predicate K002699.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 PARIETEXTM Optimized Composite mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

Indications for use as stated in the FDA summary.

Also cleared against K002699

7 other devices cite the same predicate.

  • K110663Pairetex Optimized Composite Mesh (Pco-FX Refrences)Sofradim Production · 2011
  • K110815Parietex Optimized Compostie MeshSofradim Production · 2011
  • K062915Veritas Collagen MatrixSynovis Surgical Innovations · 20061 recall
  • K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production · 2005
  • K040998Modification to Parietex Composite (Pco) MeshSofradim Production · 2004
  • K033376Ugytex MeshSofradim Production · 2004

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/K110816 · printed Nov 5, 2026

Cite this page

510(k) Report. “K110816: Parietex Optimized Composite Mesh (Pco-Osx References).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110816

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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