# K081126: Parietex Composite Mono PM Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Sofradim Production
- Decided: Aug 13, 2008 after 114 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K991400 (1999). 5 ancestors in all.
15 later devices descend from it; 4 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)
- K040998: Modification to Parietex Composite (Pco) Mesh, Sofradim Production (2004) Summary page 1.

## Most influential descendants
- K090858: Parietex Monofilament Polyester Mesh (2009), 14 descendants of its own
- 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

## Recalls of this device
- Oct 5, 2018 · Class II · Z-0461-2019: The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair tech

## Indications for use
The PARIETEX TM COMPOSITE Mono PM Mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The non-absorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.

Source page: https://510kreport.com/device/K081126
Methodology: https://510kreport.com/methodology