510(k) · Cleared
ClearedParietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofradim Production · FTL Mesh, Surgical, Polymeric
Cleared on Oct 28, 2014 as substantially equivalent to K103682 (Sofradim Production, 2011) and 2 other predicates after a 22-day review. Its family tree reaches back 6 generations to 1999. 5 later devices descend from it.
- Decided
- Oct 28, 2014
- Review
- 22 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K991400 (1999). 18 ancestors in all, the oldest K810428 (1981). 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK991400 Parietene Polypropylene MeshSofradim Production · 1999
- 5 generations backK033376 Ugytex MeshSofradim Production · 2004
- 4 generations backK040998 Modification to Parietex Composite (Pco) MeshSofradim Production · 2004
- 3 generations backK073287 Prevadh MeshSofradim Production · 2008
- 2 generations backK081050 Parietex Progrip MeshSofradim Production · 2008
- 1 generation backK101519 Parietex Plug and PatchSofradim Production · 2010
- This deviceK142900 Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester…Sofradim Production · 2014
- Descendant · cites it directly · 3 of its ownK220586 Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh…Sofradim Production · 2022
- Descendant · 2 generations on · 2 of its ownK232373 Progrip™ Self-Gripping Polypropylene MeshSofradim Production · 2024
- Descendant · 3 generations on · 1 of its ownK243315 ProGrip™ Self-Gripping Polypropylene MeshSofradim Production · 2025
- Descendant · 4 generations on · 0 of its ownK253956 ProGrip™ advanced self-gripping polypropylene mesh (ADG1510…Sofradim Production · 2026
- Descendant · cites it directly · 0 of its ownK143386 Progrip Laparoscopic Self-Fixating MeshSofradim Production · 2015
Most influential descendants
Showing 5 of 5 · See all- K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…Sofradim Production · 2022 · cites it directly3descendants
- K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production · 2024 · 2 generations on2descendants
- K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production · 2025 · 3 generations on1descendant
- K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026 · 4 generations on0descendants
- K143386Progrip Laparoscopic Self-Fixating MeshSofradim Production · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K991400 | Parietene Polypropylene Mesh | Sofradim Production | 1999 | — |
| −5 | K033376 | Ugytex Mesh | Sofradim Production | 2004 | — |
| −4 | K040998 | Modification to Parietex Composite (Pco) Mesh | Sofradim Production | 2004 | — |
| −3 | K073287 | Prevadh Mesh | Sofradim Production | 2008 | — |
| −2 | K081050 | Parietex Progrip Mesh | Sofradim Production | 2008 | — |
| −1 | K101519 | Parietex Plug and Patch | Sofradim Production | 2010 | — |
| 0 (this device) | K142900 | Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh)… | Sofradim Production | 2014 | — |
| +1 | K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex… | Sofradim Production | 2022 | — |
| +2 | K232373 | Progrip™ Self-Gripping Polypropylene Mesh | Sofradim Production | 2024 | — |
| +3 | K243315 | ProGrip™ Self-Gripping Polypropylene Mesh | Sofradim Production | 2025 | — |
| +4 | K253956 | ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020… | Sofradim Production | 2026 | — |
| +1 | K143386 | Progrip Laparoscopic Self-Fixating Mesh | Sofradim Production | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103682 | Parietex ProgripSummary page 7…K142900 pg. 2 of 4 Legally marketed devices to which equivalence is claimed: Parietex™ Progrip™ Mesh (K103682) Parietex™ Plug and Patch (K101519) Progrip™ Laparoscopic… | 2011 |
| * | K101519 | Parietex Plug and PatchSummary page 7…2 of 4 Legally marketed devices to which equivalence is claimed: Parietex™ Progrip™ Mesh (K103682) Parietex™ Plug and Patch (K101519) Progrip™ Laparoscopic Self-Fixating Mesh (K123479) Reason for 510(k) Submission:… | 2010 |
| * | K123479 | Progrip Laparoscopic Self-Fixating MeshSummary page 7…grip™ Mesh (K103682) Parietex™ Plug and Patch (K101519) Progrip™ Laparoscopic Self-Fixating Mesh (K123479) Reason for 510(k) Submission: The purpose of this 510(k) is to notify the Agency of the addition of another… | 2012 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 1 company; a new generation was cleared every 3.9 years on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K220586 (Sofradim Production, 2022) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Parietex™ Plug and Patch System is indicated for the reinforcement of soft tissues during repair of groin hernia defects by open approach
ProGrip™ Laparoscopic Self-Fixating Mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach
ProGrip™ Self-Gripping Polyester Mesh is indicated for inguinal and incisional hernias repair.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142900: Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), 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/K142900
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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