# K090858: Parietex Monofilament Polyester Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Sofradim Production
- Decided: May 6, 2009 after 37 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: 4 generations back to K991400 (1999). 6 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081126: Parietex Composite Mono PM Mesh, Sofradim Production (2008) Summary page 1.
- (no number) Mersilene MT: named in the summary without a submission number

## Most influential descendants
- K131969: Symbotex (TM) Composite Mesh (2013), 10 descendants of its own
- K101519: Parietex Plug and Patch (2010), 6 descendants of its own
- 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 (2014), 5 descendants of its own
- K142900: Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh (2014), 5 descendants of its own
- K150091: Versatex Monofilament Mesh (2015), 4 descendants of its own

## Indications for use
The Parietex TM Monofilament Polyester Mesh is indicated for inguinal and ventral hernia repair.

Source page: https://510kreport.com/device/K090858
Methodology: https://510kreport.com/methodology