510(k) · Cleared
ClearedSymbotex (TM) Composite 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 Aug 22, 2013 as substantially equivalent to K040998 (Sofradim Production, 2004) and 5 other predicates after a 55-day review. Its family tree reaches back 5 generations to 1999. 10 later devices descend from it.
- Decided
- Aug 22, 2013
- Review
- 55 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K991400 (1999). 17 ancestors in all, the oldest K930586 (1993). 10 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK991400 Parietene Polypropylene MeshSofradim Production · 1999
- 4 generations backK033376 Ugytex MeshSofradim Production · 2004
- 3 generations backK040998 Modification to Parietex Composite (Pco) MeshSofradim Production · 2004
- 2 generations backK081126 Parietex Composite Mono PM MeshSofradim Production · 2008 · Recalled
- 1 generation backK090858 Parietex Monofilament Polyester MeshSofradim Production · 2009
- This deviceK131969 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
- Descendant · 3 generations on · 2 of its ownK232373 Progrip™ Self-Gripping Polypropylene MeshSofradim Production · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- 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
- K232373Progrip™ Self-Gripping Polypropylene MeshSofradim Production · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K991400 | Parietene Polypropylene Mesh | Sofradim Production | 1999 | — |
| −4 | K033376 | Ugytex Mesh | Sofradim Production | 2004 | — |
| −3 | K040998 | Modification to Parietex Composite (Pco) Mesh | Sofradim Production | 2004 | — |
| −2 | K081126 | Parietex Composite Mono PM Mesh | Sofradim Production | 2008 | 1 |
| −1 | K090858 | Parietex Monofilament Polyester Mesh | Sofradim Production | 2009 | — |
| 0 (this device) | 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 | — |
| +3 | K232373 | Progrip™ Self-Gripping Polypropylene Mesh | Sofradim Production | 2024 | — |
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 |
|---|---|---|
| 2013 | 1 | 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? (6)
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…egulation: 21 CIFR 878.3300 Product Code: FTL Legally marketed devices to which equivalence is claimed: PARIETEX TM Composite Mesh (K040998) PARIETEXTM Optimized Composite Mesh (K1 10663 and K1 10816) PARIE… | 2004 |
| * | K110663 | Pairetex Optimized Composite Mesh (Pco-FX Refrences)Summary page 1…FTL Legally marketed devices to which equivalence is claimed: PARIETEX TM Composite Mesh (K040998) PARIETEXTM Optimized Composite Mesh (K1 10663 and K1 10816) PARIETEX ' Composite Ventral Patch (K120506) PARIETE… | 2011 |
| * | K110816 | Parietex Optimized Composite Mesh (Pco-Osx References)Summary page 1…y marketed devices to which equivalence is claimed: PARIETEX TM Composite Mesh (K040998) PARIETEXTM Optimized Composite Mesh (K1 10663 and K1 10816) PARIETEX ' Composite Ventral Patch (K120506) PARIETEX TM Monofiam… | 2011 |
| * | K120506 | Parietex Composite Ventral PatchSummary page 1…(K040998) PARIETEXTM Optimized Composite Mesh (K1 10663 and K1 10816) PARIETEX ' Composite Ventral Patch (K120506) PARIETEX TM Monofiament Polyester Mesh (K090858) PARIETEX m Compos… | 2012 |
| * | K090858 | Parietex Monofilament Polyester MeshSummary page 1…1 10663 and K1 10816) PARIETEX ' Composite Ventral Patch (K120506) PARIETEX TM Monofiament Polyester Mesh (K090858) PARIETEX m Composite Mono PM Mesh (K081126) Reason for 510(k) submission: To obtain market clear… | 2009 |
| * | K081126 | Parietex Composite Mono PM MeshSummary page 1…Ventral Patch (K120506) PARIETEX TM Monofiament Polyester Mesh (K090858) PARIETEX m Composite Mono PM Mesh (K081126) Reason for 510(k) submission: To obtain market clearance of the Symbotex M Composite Mesh(s). Device description: Sy… | 2008 |
What descends from it? (10)
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 14 years and passes through 1 company; a new generation was cleared every 4.3 years on median.
- 5 of the 17 ancestors have a recall of any class.
- Of its descendants, K142908 (Sofradim Production, 2014) has gone furthest, with 5 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. 2013, 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 Symbotex Composite Mesh is intended for the reinforcement of soft tissue where a weakness exists such as the repair of the primary abdominal wall and incisional hernias.
The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, 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/K131969 · printed Nov 4, 2026
Cite this page
510(k) Report. “K131969: Symbotex (TM) Composite Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K131969
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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