510(k) · Cleared
Recalled · Class II · 2023Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)
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 Mar 9, 2018 as substantially equivalent to K982532 (Cogent, 1999) and 5 other predicates after an 85-day review. Its family tree reaches back 5 generations to 1999. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 9, 2018
- Review
- 85 days
- Class
- Class II
- Product code
- FTL
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 5 generations to K991400 (1999). 14 ancestors in all, the oldest K930586 (1993). 4 later devices descend from it, 1 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 backK050187 Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production · 2005
- 1 generation backK110816 Parietex Optimized Composite Mesh (Pco-Osx References)Sofradim Production · 2011
- This deviceK173796 Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D…Sofradim Production · 2018
- 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 |
|---|---|---|---|---|---|
| −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 | K050187 | Parietex Composite Pco-OS and Pco-OB Meshes | Sofradim Production | 2005 | — |
| −1 | K110816 | Parietex Optimized Composite Mesh (Pco-Osx References) | Sofradim Production | 2011 | — |
| 0 (this device) | K173796 | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical… | Sofradim Production | 2018 | — |
| +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 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 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? (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 |
|---|---|---|---|
| * | K982532 | ParietexSummary page 6…Regulation number: 21 CFR 878.3300 Predicate Devices: Parietex® Surgical Mesh (new names Parietex™ Hydrophilic 2D, Trade/Proprietary name 3D, Anatomical Mesh) (K982532) (510(k) Number) Parietex™ Composite Mesh (K040998, K050187) Parietex™ Optimized Composite Mesh (… | 1999 |
| * | K040998 | Modification to Parietex Composite (Pco) MeshSummary page 6…Parietex® Surgical Mesh (new names Parietex™ Hydrophilic 2D, Trade/Proprietary name 3D, Anatomical Mesh) (K982532) (510(k) Number) Parietex™ Composite Mesh (K040998, K050187) Parietex™ Optimized Composite Mesh (K110663, K110815, K110816)… | 2004 |
| * | K050187 | Parietex Composite Pco-OS and Pco-OB MeshesSummary page 6…tex® Surgical Mesh (new names Parietex™ Hydrophilic 2D, Trade/Proprietary name 3D, Anatomical Mesh) (K982532) (510(k) Number) Parietex™ Composite Mesh (K040998, K050187) Parietex™ Optimized Composite Mesh (K110663, K110815, K110816)… | 2005 |
| * | K110663 | Pairetex Optimized Composite Mesh (Pco-FX Refrences)Summary page 6…etary name 3D, Anatomical Mesh) (K982532) (510(k) Number) Parietex™ Composite Mesh (K040998, K050187) Parietex™ Optimized Composite Mesh (K110663, K110815, K110816) No reference devices were used in this submission. Common na… | 2011 |
| * | K110815 | Parietex Optimized Compostie MeshSummary page 6…e 3D, Anatomical Mesh) (K982532) (510(k) Number) Parietex™ Composite Mesh (K040998, K050187) Parietex™ Optimized Composite Mesh (K110663, K110815, K110816) No reference devices were used in this submission. Common name:… | 2011 |
| * | K110816 | Parietex Optimized Composite Mesh (Pco-Osx References)Summary page 6…(510(k) Number) Parietex™ Composite Mesh (K040998, K050187) Parietex™ Optimized Composite Mesh (K110663, K110815, K110816) No reference devices were used in this submission. Common name: Surgical Mesh Classificati… | 2011 |
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 |
|---|---|---|---|---|
| Jan 11, 2023 | Class II | Z-1183-2023 | Under Investigation by firm | Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of implant |
| Jan 13, 2021 | Class II | Z-1142-2021 | Under Investigation by firm | incorrect device is contained in the package. The packaging label indicates that the device is for left side use, the product inside the package is for right side use. Use of an opposite side mesh can result in implant failure and hernia… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 1 company; a new generation was cleared every 4.5 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K220586 (Sofradim Production, 2022) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K982532.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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™ Hydrophilic 2D, 3D, Anatomical Mesh is intended for the repair of inguinal and incisional hernias 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-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the…
Read the full statement (155 words)
Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh is intended for the repair of inguinal and incisional hernias
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-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.
Parietex™ Optimized 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-absorbable threedimensional 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/K173796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173796: Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173796
Report an extraction error
Are you the manufacturer?
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