510(k) Report

510(k) · Cleared

Cleared

Progrip Laparoscopic Self-Fixating Mesh

K123479510(k) SpecialCleared Dec 11, 201228-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 Dec 11, 2012 as substantially equivalent to K120897 (Sofradim Production, 2012) after a 28-day review. Its family tree reaches back 1 generation to 2012. 6 later devices descend from it.

Decided
Dec 11, 2012
Review
28 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K120897 (2012). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2022: 1 descendant cleared2015: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK120897 · Progrip Laparscopic Self-Fixating Mesh · Sofradim Production · 20122010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K120897 · Progrip Laparscopic Self-Fixating Mesh · Sofradim Production · 20120+5
  1. Root · 1 generation backK120897 Progrip Laparscopic Self-Fixating MeshSofradim Production · 2012
  2. This deviceK123479 Progrip Laparoscopic Self-Fixating MeshSofradim Production · 2012
  3. Descendant · cites it directly · 5 of its ownK142900 Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester…Sofradim Production · 2014
  4. Descendant · 2 generations on · 3 of its ownK220586 Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh…Sofradim Production · 2022
  5. Descendant · 3 generations on · 2 of its ownK232373 Progrip™ Self-Gripping Polypropylene MeshSofradim Production · 2024
  6. Descendant · 4 generations on · 1 of its ownK243315 ProGrip™ Self-Gripping Polypropylene MeshSofradim Production · 2025
  7. Descendant · 5 generations on · 0 of its ownK253956 ProGrip™ advanced self-gripping polypropylene mesh (ADG1510…Sofradim Production · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12022: 12024: 12025: 12026: 1
2014high 1 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 6 · See all
  • K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug…Sofradim Production · 2014 · cites it directly5descendants
  • K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…Sofradim Production · 2022 · 2 generations on3descendants
  • K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production · 2024 · 3 generations on2descendants
  • K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production · 2025 · 4 generations on1descendant
  • K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K120897Progrip Laparscopic Self-Fixating MeshSofradim Production2012—
0 (this device)K123479Progrip Laparoscopic Self-Fixating MeshSofradim Production2012—
+1K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh)…Sofradim Production2014—
+2K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex…Sofradim Production2022—
+3K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production2024—
+4K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production2025—
+5K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020…Sofradim Production2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
202210
202410
202510
202610
FIG. 1 — Lineage of K123479, 2012–2026Source: 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
*K120897Progrip Laparscopic Self-Fixating Mesh
Summary page 2
…PROGRIPTM Laparoscopic Self-fixating Mesh Legally marketed devices to which equivalence is claimed: PROGRIP Tm Laparoscopic Self-Fixating Mesh (K1 20897) Reason for 510O(k) Submission: To propose the removal of a final product specification (lower…
Sofradim Production2012—

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug…Sofradim Production20145

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?

  • Its one ancestor has no recall.
  • Of its descendants, K142900 (Sofradim Production, 2014) 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. 2012, 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?

PROGRIP™ Laparoscopic Self-Fixating Mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach.

Indications for use as stated in the FDA summary.

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/K123479 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123479: Progrip Laparoscopic Self-Fixating Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123479

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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