510(k) · Cleared
ClearedModification to Parietex Composite (Pco) 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 Apr 29, 2004 as substantially equivalent to K002699 (Medical Device Consultants, Inc., 2001) and 1 other predicate after a 10-day review. Its family tree reaches back 2 generations to 1999. 61 later devices descend from it.
- Decided
- Apr 29, 2004
- Review
- 10 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K991400 (1999). 4 ancestors in all. 61 later devices descend from it, 13 citing it directly.
- Root · 2 generations backK991400 Parietene Polypropylene MeshSofradim Production · 1999
- 1 generation backK033376 Ugytex MeshSofradim Production · 2004
- This deviceK040998 Modification to Parietex Composite (Pco) MeshSofradim Production · 2004
- Descendant · cites it directly · 31 of its ownK050187 Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production · 2005
- Descendant · cites it directly · 17 of its ownK073287 Prevadh MeshSofradim Production · 2008
- Descendant · cites it directly · 15 of its ownK081126 Parietex Composite Mono PM MeshSofradim Production · 2008 · Recalled
- Descendant · 2 generations on · 15 of its ownK081050 Parietex Progrip MeshSofradim Production · 2008
- Descendant · cites it directly · 15 of its ownK062915 Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · Recalled
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production · 2005 · cites it directly31descendants
- K073287Prevadh MeshSofradim Production · 2008 · cites it directly17descendants
- K081126Parietex Composite Mono PM MeshSofradim Production · 2008 · cites it directly15descendants
- K081050Parietex Progrip MeshSofradim Production · 2008 · 2 generations on15descendants
- K062915Veritas Collagen MatrixSynovis Surgical Innovations · 2006 · cites it directly15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991400 | Parietene Polypropylene Mesh | Sofradim Production | 1999 | — |
| −1 | K033376 | Ugytex Mesh | Sofradim Production | 2004 | — |
| 0 (this device) | K040998 | Modification to Parietex Composite (Pco) Mesh | Sofradim Production | 2004 | — |
| +1 | K050187 | Parietex Composite Pco-OS and Pco-OB Meshes | Sofradim Production | 2005 | — |
| +1 | K073287 | Prevadh Mesh | Sofradim Production | 2008 | — |
| +1 | K081126 | Parietex Composite Mono PM Mesh | Sofradim Production | 2008 | 1 |
| +2 | K081050 | Parietex Progrip Mesh | Sofradim Production | 2008 | — |
| +1 | K062915 | Veritas Collagen Matrix | Synovis Surgical Innovations | 2006 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 9 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K002699 | Parietex Composite (Pco) MeshSummary page 1…Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh 3. PREDICATE DEVICES Sofradim PARIETEX®"COMPOS ITE Meshes, K002699 Sofradimn UGYTEX®O Mesh, K033 376 4. DEVICE DESCRIPTION The PARIETEX'~COMPOSITE Mesh is a surgical… | 2001 |
| * | K033376 | Ugytex MeshSummary page 1…sh Classification Name: Surgical Mesh 3. PREDICATE DEVICES Sofradim PARIETEX®"COMPOS ITE Meshes, K002699 Sofradimn UGYTEX®O Mesh, K033 376 4. DEVICE DESCRIPTION The PARIETEX'~COMPOSITE Mesh is a surgical mesh used during open (laparotomy)… | 2004 |
What descends from it? (61)
See all 6113 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050187 | Parietex Composite Pco-OS and Pco-OB Meshes | 2005 | 31 |
| K073287 | Prevadh Mesh | 2008 | 17 |
| K081126 | Parietex Composite Mono PM Mesh | 2008 | 15 |
| K062915 | Veritas Collagen Matrix | 2006 | 15 |
| K110816 | Parietex Optimized Composite Mesh (Pco-Osx References) | 2011 | 14 |
| K110663 | Pairetex Optimized Composite Mesh (Pco-FX Refrences) | 2011 | 12 |
| K120506 | Parietex Composite Ventral Patch | 2012 | 11 |
| K131969 | Symbotex (TM) Composite Mesh | 2013 | 10 |
| K111584 | Xylos Macro-Porous Surgical Mesh | 2011 | 5 |
| K110815 | Parietex Optimized Compostie Mesh | 2011 | 5 |
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 5 years and passes through 1 company; a new generation was cleared every 4.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K050187 (Sofradim Production, 2005) has gone furthest, with 31 descendants of its own.
- 7 other devices also cite its predicate K002699.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PARIETEX® Composite Mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair, and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-resorbable three-dimensional polyester mesh provides long-term reinforcement of soft tissues. On the opposite side, the resorbable 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/K040998 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040998: Modification to Parietex Composite (Pco) Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040998
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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