510(k) · Cleared
ClearedParietex Composite Ventral Patch
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 13, 2012 as substantially equivalent to K040998 (Sofradim Production, 2004) and 2 other predicates after a 113-day review. Its family tree reaches back 3 generations to 1999. 11 later devices descend from it.
- Decided
- Jun 13, 2012
- Review
- 113 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K991400 (1999). 7 ancestors in all. 11 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK991400 Parietene Polypropylene MeshSofradim Production · 1999
- 2 generations backK033376 Ugytex MeshSofradim Production · 2004
- 1 generation backK040998 Modification to Parietex Composite (Pco) MeshSofradim Production · 2004
- This deviceK120506 Parietex Composite Ventral PatchSofradim Production · 2012
- Descendant · cites it directly · 10 of its ownK131969 Symbotex (TM) Composite MeshSofradim Production · 2013
- Descendant · cites it directly · 5 of its ownK142908 Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight…Sofradim Production · 2014 · Recalled
- Descendant · 2 generations on · 4 of its ownK150091 Versatex Monofilament MeshSofradim Production · 2015 · Recalled
- Descendant · 2 generations on · 3 of its ownK220586 Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh…Sofradim Production · 2022
- Descendant · cites it directly · 3 of its ownK130997 NeoveilGunze Limited · 2013
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K131969Symbotex (TM) Composite MeshSofradim Production · 2013 · cites it directly10descendants
- K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex…Sofradim Production · 2014 · cites it directly5descendants
- K150091Versatex Monofilament MeshSofradim Production · 2015 · 2 generations on4descendants
- K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…Sofradim Production · 2022 · 2 generations on3descendants
- K130997NeoveilGunze Limited · 2013 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991400 | Parietene Polypropylene Mesh | Sofradim Production | 1999 | — |
| −2 | K033376 | Ugytex Mesh | Sofradim Production | 2004 | — |
| −1 | K040998 | Modification to Parietex Composite (Pco) Mesh | Sofradim Production | 2004 | — |
| 0 (this device) | K120506 | Parietex Composite Ventral Patch | Sofradim Production | 2012 | — |
| +1 | K131969 | Symbotex (TM) Composite Mesh | Sofradim Production | 2013 | — |
| +1 | K142908 | Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh)… | Sofradim Production | 2014 | 1 |
| +2 | K150091 | Versatex Monofilament Mesh | Sofradim Production | 2015 | 2 |
| +2 | K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex… | Sofradim Production | 2022 | — |
| +1 | K130997 | Neoveil | Gunze Limited | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K040998 | Modification to Parietex Composite (Pco) MeshSummary page 1…21 CFR 878.3300 Product Code: FTL Legally marketed devices to which equivalence is claimed: Parietex Tm Composite Mesh (K040998) Bard Ventralex® Patch (K021736 and K<024008) Reason for 510(k) submission: To introduc… | 2004 |
| * | K021736 | Bard Ventralex Hernia Patch, Models 0010302, 0010301Summary page 1…FTL Legally marketed devices to which equivalence is claimed: Parietex Tm Composite Mesh (K040998) Bard Ventralex® Patch (K021736 and K<024008) Reason for 510(k) submission: To introduce the ParietexTM Composite Ventral Patch which is a… | 2002 |
| * | K024008 | Small Bard Ventralex PatchSummary page 2…equivalent to the predicate devices, Parietexrl Composite Mesh (K040998) and Bard Ventralex®O Patch (K021 736 and K024008), in terms of its technological characteristics and material.… | 2003 |
What descends from it? (11)
See all 113 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 13 years and passes through 1 company; a new generation was cleared every 4.5 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K131969 (Sofradim Production, 2013) has gone furthest, with 10 descendants of its own.
- 12 other devices also cite its predicate K040998.
How does its category compare?
All FTL devicesFTL 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
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?
The PARIETEXTM composite ventral patch is used for the reinforcement of soft tissues during surgical repair. It is indicated for the treatment of ventral defects (primary and incisional hernias). The three-dimensional non-absorbable monofilament polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120506 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120506: Parietex Composite Ventral Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120506
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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