# K040998: Modification to Parietex Composite (Pco) Mesh

- Pathway: 510(k) (Special)
- Applicant: Sofradim Production
- Decided: Apr 29, 2004 after 10 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991400 (1999). 4 ancestors in all.
61 later devices descend from it; 13 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002699: Parietex Composite (Pco) Mesh, Medical Device Consultants, Inc. (2001) Summary page 1.
- K033376: Ugytex Mesh, Sofradim Production (2004) Summary page 1.

## Most influential descendants
- K050187: Parietex Composite Pco-OS and Pco-OB Meshes (2005), 31 descendants of its own
- K073287: Prevadh Mesh (2008), 17 descendants of its own
- K081126: Parietex Composite Mono PM Mesh (2008), 15 descendants of its own
- K081050: Parietex Progrip Mesh (2008), 15 descendants of its own
- K062915: Veritas Collagen Matrix (2006), 15 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K040998
Methodology: https://510kreport.com/methodology