510(k) · Cleared
ClearedProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)
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 May 21, 2026 as substantially equivalent to K243315 (Sofradim Production, 2025) after a 162-day review. Its family tree reaches back 11 generations to 1999.
- Decided
- May 21, 2026
- Review
- 162 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K991400 (1999). 37 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.
- Root · 11 generations backK991400 Parietene Polypropylene MeshSofradim Production · 1999
- 7 generations between
- 3 generations backK220586 Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh…Sofradim Production · 2022
- 2 generations backK232373 Progrip™ Self-Gripping Polypropylene MeshSofradim Production · 2024
- 1 generation backK243315 ProGrip™ Self-Gripping Polypropylene MeshSofradim Production · 2025
- This deviceK253956 ProGrip™ advanced self-gripping polypropylene mesh (ADG1510…Sofradim Production · 2026
Show all 11 generations
- Root · 11 generations backK991400 Parietene Polypropylene MeshSofradim Production · 1999
- 10 generations backK033376 Ugytex MeshSofradim Production · 2004
- 9 generations backK040998 Modification to Parietex Composite (Pco) MeshSofradim Production · 2004
- 8 generations backK081126 Parietex Composite Mono PM MeshSofradim Production · 2008 · Recalled
- 7 generations backK090858 Parietex Monofilament Polyester MeshSofradim Production · 2009
- 6 generations backK131969 Symbotex (TM) Composite MeshSofradim Production · 2013
- 5 generations backK142908 Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight…Sofradim Production · 2014 · Recalled
- 4 generations backK150091 Versatex Monofilament MeshSofradim Production · 2015 · Recalled
- 3 generations backK220586 Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh…Sofradim Production · 2022
- 2 generations backK232373 Progrip™ Self-Gripping Polypropylene MeshSofradim Production · 2024
- 1 generation backK243315 ProGrip™ Self-Gripping Polypropylene MeshSofradim Production · 2025
- This deviceK253956 ProGrip™ advanced self-gripping polypropylene mesh (ADG1510…Sofradim Production · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K991400 | Parietene Polypropylene Mesh | Sofradim Production | 1999 | — |
| −10 | K033376 | Ugytex Mesh | Sofradim Production | 2004 | — |
| −9 | K040998 | Modification to Parietex Composite (Pco) Mesh | Sofradim Production | 2004 | — |
| −8 | K081126 | Parietex Composite Mono PM Mesh | Sofradim Production | 2008 | 1 |
| −7 | K090858 | Parietex Monofilament Polyester Mesh | Sofradim Production | 2009 | — |
| −6 | K131969 | Symbotex (TM) Composite Mesh | Sofradim Production | 2013 | — |
| −5 | K142908 | Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh)… | Sofradim Production | 2014 | 1 |
| −4 | K150091 | Versatex Monofilament Mesh | Sofradim Production | 2015 | 2 |
| −3 | K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex… | Sofradim Production | 2022 | — |
| −2 | K232373 | Progrip™ Self-Gripping Polypropylene Mesh | Sofradim Production | 2024 | — |
| −1 | K243315 | ProGrip™ Self-Gripping Polypropylene Mesh | Sofradim Production | 2025 | — |
| 0 (this device) | K253956 | ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020… | Sofradim Production | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K243315 | ProGrip™ Self-Gripping Polypropylene MeshSummary page 5…n name: Mesh, Surgical, Polymeric Product code: FTL Regulation number: 21 CFR 878.3300 510(k) Number: K243315 Manufacturer: Sofradim Production (subsidiary of Covidien llc) 116, avenue du Formans… | 2025 |
| † | K143386 | Progrip Laparoscopic Self-Fixating Mesh | 2015 |
| † | K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- 9 of the 37 ancestors have a recall of any class.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
ProGrip™ advanced self-gripping polypropylene mesh is intended for use in reinforcement of abdominal wall soft tissues where weakness exists. It is indicated for use in the extraperitoneal space during ventral hernia repair procedures, utilizing either conventional laparoscopic or robotic-assisted surgical techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253956 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253956: ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253956
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026