# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Sofradim Production
- Decided: Mar 9, 2018 after 85 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K991400 (1999). 14 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982532: Parietex, Cogent (1999) Summary page 6.
- K040998: Modification to Parietex Composite (Pco) Mesh, Sofradim Production (2004) Summary page 6.
- K050187: Parietex Composite Pco-OS and Pco-OB Meshes, Sofradim Production (2005) Summary page 6.
- K110663: Pairetex Optimized Composite Mesh (Pco-FX Refrences), Sofradim Production (2011) Summary page 6.
- K110815: Parietex Optimized Compostie Mesh, Sofradim Production (2011) Summary page 6.
- K110816: Parietex Optimized Composite Mesh (Pco-Osx References), Sofradim Production (2011) Summary page 6.

## Most influential descendants
- K220586: Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh (2022), 3 descendants of its own
- K232373: Progrip™ Self-Gripping Polypropylene Mesh (2024), 2 descendants of its own
- K243315: ProGrip™ Self-Gripping Polypropylene Mesh (2025), 1 descendant of its own
- K253956: ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) (2026), 0 descendants of its own

## Recalls of this device
- Jan 11, 2023 · Class II · Z-1183-2023: 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: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K173796
Methodology: https://510kreport.com/methodology