510(k) · Cleared
ClearedSymbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament 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 Jun 22, 2022 as substantially equivalent to K142908 (Sofradim Production, 2014) and 3 other predicates after a 113-day review. Its family tree reaches back 8 generations to 1999. 3 later devices descend from it.
- Decided
- Jun 22, 2022
- Review
- 113 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K991400 (1999). 34 ancestors in all, the oldest K810428 (1981). 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK991400 Parietene Polypropylene MeshSofradim Production · 1999
- 7 generations backK033376 Ugytex MeshSofradim Production · 2004
- 6 generations backK040998 Modification to Parietex Composite (Pco) MeshSofradim Production · 2004
- 5 generations backK081126 Parietex Composite Mono PM MeshSofradim Production · 2008 · Recalled
- 4 generations backK090858 Parietex Monofilament Polyester MeshSofradim Production · 2009
- 3 generations backK131969 Symbotex (TM) Composite MeshSofradim Production · 2013
- 2 generations backK142908 Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight…Sofradim Production · 2014 · Recalled
- 1 generation backK150091 Versatex Monofilament MeshSofradim Production · 2015 · Recalled
- This deviceK220586 Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh…Sofradim Production · 2022
- Descendant · cites it directly · 2 of its ownK232373 Progrip™ Self-Gripping Polypropylene MeshSofradim Production · 2024
- Descendant · 2 generations on · 1 of its ownK243315 ProGrip™ Self-Gripping Polypropylene MeshSofradim Production · 2025
- Descendant · 3 generations on · 0 of its ownK253956 ProGrip™ advanced self-gripping polypropylene mesh (ADG1510…Sofradim Production · 2026
Most influential descendants
Showing 3 of 3 · See all- K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production · 2024 · cites it directly2descendants
- K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production · 2025 · 2 generations on1descendant
- K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K991400 | Parietene Polypropylene Mesh | Sofradim Production | 1999 | — |
| −7 | K033376 | Ugytex Mesh | Sofradim Production | 2004 | — |
| −6 | K040998 | Modification to Parietex Composite (Pco) Mesh | Sofradim Production | 2004 | — |
| −5 | K081126 | Parietex Composite Mono PM Mesh | Sofradim Production | 2008 | 1 |
| −4 | K090858 | Parietex Monofilament Polyester Mesh | Sofradim Production | 2009 | — |
| −3 | K131969 | Symbotex (TM) Composite Mesh | Sofradim Production | 2013 | — |
| −2 | K142908 | Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh)… | Sofradim Production | 2014 | 1 |
| −1 | K150091 | Versatex Monofilament Mesh | Sofradim Production | 2015 | 2 |
| 0 (this device) | K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex… | Sofradim Production | 2022 | — |
| +1 | K232373 | Progrip™ Self-Gripping Polypropylene Mesh | Sofradim Production | 2024 | — |
| +2 | K243315 | ProGrip™ Self-Gripping Polypropylene Mesh | Sofradim Production | 2025 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K142908 | Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex…Summary page 7…Panel number and product code: 79 FTL Regulation number: 21 CFR 878.3300 510(k) Number: Symbotex™ Composite Mesh: K142908 ProGrip™ Self-Gripping Polyester Mesh: K142900 Parietex™ Hydrophilic 2D 3D… | 2014 |
| * | K142900 | Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug…Summary page 7…Regulation number: 21 CFR 878.3300 510(k) Number: Symbotex™ Composite Mesh: K142908 ProGrip™ Self-Gripping Polyester Mesh: K142900 Parietex™ Hydrophilic 2D 3D Anatomical Mesh: K173796 Versatex™ Monofilament… | 2014 |
| * | K173796 | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh)…Summary page 7…Composite Mesh: K142908 ProGrip™ Self-Gripping Polyester Mesh: K142900 Parietex™ Hydrophilic 2D 3D Anatomical Mesh: K173796 Versatex™ Monofilament Mesh: K150091 Manufacturer: Sofradim Production (subsidiary of Cov… | 2018 |
| * | K150091 | Versatex Monofilament MeshSummary page 7…-Gripping Polyester Mesh: K142900 Parietex™ Hydrophilic 2D 3D Anatomical Mesh: K173796 Versatex™ Monofilament Mesh: K150091 Manufacturer: Sofradim Production (subsidiary of Covidien llc) 116, avenue du Formans… | 2015 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232373 | Progrip™ Self-Gripping Polypropylene Mesh | 2024 | 2 |
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 23 years and passes through 1 company; a new generation was cleared every 4.3 years on median.
- 9 of the 34 ancestors have a recall of any class.
- Of its descendants, K232373 (Sofradim Production, 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K142908.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Symbotex™ Composite Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving primary abdominal wall and incisional hernia surgeries. ProGrip™ Self-Gripping Polyester Mesh is intended for use in reinforcement of abdominal wall soft tissues where a weakness exists in procedure involving inguinal and incisional hernias repair. Parietex™ Hydrophilic 2D 3D Anatomical Mesh is intended for…
Read the full statement (104 words)
Symbotex™ Composite Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving primary abdominal wall and incisional hernia surgeries.
ProGrip™ Self-Gripping Polyester Mesh is intended for use in reinforcement of abdominal wall soft tissues where a weakness exists in procedure involving inguinal and incisional hernias repair.
Parietex™ Hydrophilic 2D 3D Anatomical Mesh is intended for reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving inguinal and incisional hernia repairs.
Versatex™ Monofilament Mesh is intended for reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernia repairs.
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/K220586 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220586: Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220586
Report an extraction error
Are you the manufacturer?
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