510(k) · Cleared
Recalled · Class II · 2018Versatex 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 May 26, 2015 as substantially equivalent to K142908 (Sofradim Production, 2014) after a 130-day review. Its family tree reaches back 7 generations to 1999. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- May 26, 2015
- Review
- 130 days
- Class
- Class II
- Product code
- FTL
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 7 generations to K991400 (1999). 19 ancestors in all, the oldest K930586 (1993). 4 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK991400 Parietene Polypropylene MeshSofradim Production · 1999
- 6 generations backK033376 Ugytex MeshSofradim Production · 2004
- 5 generations backK040998 Modification to Parietex Composite (Pco) MeshSofradim Production · 2004
- 4 generations backK081126 Parietex Composite Mono PM MeshSofradim Production · 2008 · Recalled
- 3 generations backK090858 Parietex Monofilament Polyester MeshSofradim Production · 2009
- 2 generations backK131969 Symbotex (TM) Composite MeshSofradim Production · 2013
- 1 generation backK142908 Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight…Sofradim Production · 2014 · Recalled
- This deviceK150091 Versatex Monofilament MeshSofradim Production · 2015
- 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
Most influential descendants
Showing 4 of 4 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K991400 | Parietene Polypropylene Mesh | Sofradim Production | 1999 | — |
| −6 | K033376 | Ugytex Mesh | Sofradim Production | 2004 | — |
| −5 | K040998 | Modification to Parietex Composite (Pco) Mesh | Sofradim Production | 2004 | — |
| −4 | K081126 | Parietex Composite Mono PM Mesh | Sofradim Production | 2008 | 1 |
| −3 | K090858 | Parietex Monofilament Polyester Mesh | Sofradim Production | 2009 | — |
| −2 | K131969 | Symbotex (TM) Composite Mesh | Sofradim Production | 2013 | — |
| −1 | K142908 | Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh)… | Sofradim Production | 2014 | 1 |
| 0 (this device) | K150091 | Versatex Monofilament Mesh | Sofradim Production | 2015 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 4…ode FTL Legally marketed devices to Mersilene™ Polyester Fiber Mesh – Preamendment device which equivalence is claimed Symbotex™ Composite Mesh – K142908 Reason for 510(k) submission To obtain market clearance of Versatex™ Monofilament Mesh. Device description Versat… | 2014 |
| * | — | Mersilene™ Polyester Fiber Mesh Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D… | 2022 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2018 | Class II | Z-2427-2018 | Other | Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices. |
| Feb 23, 2018 | Class II | Z-1523-2018 | Other | There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware of risks in using the device in Transversus… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
- 6 of the 19 ancestors have a recall of any class.
- Of its descendants, K220586 (Sofradim Production, 2022) has gone furthest, with 3 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. 2015, 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?
Versatex™ Monofilament Mesh is intended for the repair of abdominal wail hemias or other fascial deficiencies that require the addition of a reinforcing material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150091: 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/K150091
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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