510(k) · Cleared
Recalled · Class II · 2018Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex 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 Nov 14, 2014 as substantially equivalent to K090858 (Sofradim Production, 2009) and 3 other predicates after a 39-day review. Its family tree reaches back 6 generations to 1999. 5 later devices descend from it. It has been recalled once.
- Decided
- Nov 14, 2014
- Review
- 39 days
- Class
- Class II
- Product code
- FTL
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 6 generations to K991400 (1999). 18 ancestors in all, the oldest K930586 (1993). 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK991400 Parietene Polypropylene MeshSofradim Production · 1999
- 5 generations backK033376 Ugytex MeshSofradim Production · 2004
- 4 generations backK040998 Modification to Parietex Composite (Pco) MeshSofradim Production · 2004
- 3 generations backK081126 Parietex Composite Mono PM MeshSofradim Production · 2008 · Recalled
- 2 generations backK090858 Parietex Monofilament Polyester MeshSofradim Production · 2009
- 1 generation backK131969 Symbotex (TM) Composite MeshSofradim Production · 2013
- This deviceK142908 Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight…Sofradim Production · 2014
- Descendant · cites it directly · 4 of its ownK150091 Versatex Monofilament MeshSofradim Production · 2015 · Recalled
- 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 5 of 5 · See all- K150091Versatex Monofilament MeshSofradim Production · 2015 · cites it directly4descendants
- 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 |
|---|---|---|---|---|---|
| −6 | K991400 | Parietene Polypropylene Mesh | Sofradim Production | 1999 | — |
| −5 | K033376 | Ugytex Mesh | Sofradim Production | 2004 | — |
| −4 | K040998 | Modification to Parietex Composite (Pco) Mesh | Sofradim Production | 2004 | — |
| −3 | K081126 | Parietex Composite Mono PM Mesh | Sofradim Production | 2008 | 1 |
| −2 | K090858 | Parietex Monofilament Polyester Mesh | Sofradim Production | 2009 | — |
| −1 | K131969 | Symbotex (TM) Composite Mesh | Sofradim Production | 2013 | — |
| 0 (this device) | K142908 | Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh)… | Sofradim Production | 2014 | — |
| +1 | K150091 | Versatex Monofilament Mesh | Sofradim Production | 2015 | 2 |
| +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 |
|---|---|---|
| 2015 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K090858 | Parietex Monofilament Polyester MeshSummary page 8…Page 2 of 5 Legally marketed devices to which equivalence is claimed: Parietex™ Monofilament Polyester Mesh (K090858) Parietex™ Composite Mono PM Mesh (K081126) Parietex™ C… | 2009 |
| * | K081126 | Parietex Composite Mono PM MeshSummary page 8…ed devices to which equivalence is claimed: Parietex™ Monofilament Polyester Mesh (K090858) Parietex™ Composite Mono PM Mesh (K081126) Parietex™ Composite Ventral Patch (K120506) Symbotex™… | 2008 |
| * | K120506 | Parietex Composite Ventral PatchSummary page 8…er Mesh (K090858) Parietex™ Composite Mono PM Mesh (K081126) Parietex™ Composite Ventral Patch (K120506) Symbotex™ Composite Mesh (K131969) Reason for 510(k) Submission: The p… | 2012 |
| * | K131969 | Symbotex (TM) Composite MeshSummary page 8…te Mono PM Mesh (K081126) Parietex™ Composite Ventral Patch (K120506) Symbotex™ Composite Mesh (K131969) Reason for 510(k) Submission: The purpose of this 510(k) is to notify the Agency of the addition of another… | 2013 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 5, 2018 | Class II | Z-0461-2019 | Unknown/Undetermined by firm | The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair technique. In these reports, product… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 1 company; a new generation was cleared every 4.3 years on median.
- 5 of the 18 ancestors have a recall of any class.
- Of its descendants, K150091 (Sofradim Production, 2015) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K090858.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Parietex™ lightweight mesh is indicated for inguinal and ventral hernia repair. The PARIETEX™ Parastomal Mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The non-absorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera. The Parietex™…
Read the full statement (183 words)
Parietex™ lightweight mesh is indicated for inguinal and ventral hernia repair.
The PARIETEX™ Parastomal Mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias.
The non-absorbable polyester mesh provides long term reinforcement of soft tissues.
The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.
The Parietex™ 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.
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.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142908 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142908: Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142908
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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