# K120506: Parietex Composite Ventral Patch

- Pathway: 510(k) (Traditional)
- Applicant: Sofradim Production
- Decided: Jun 13, 2012 after 113 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: 3 generations back to K991400 (1999). 7 ancestors in all.
11 later devices descend from it; 3 cite 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)
- K040998: Modification to Parietex Composite (Pco) Mesh, Sofradim Production (2004) Summary page 1.
- K021736: Bard Ventralex Hernia Patch, Models 0010302, 0010301, C.R. Bard, Inc. (2002) Summary page 1.
- K024008: Small Bard Ventralex Patch, C.R. Bard, Inc. (2003) Summary page 2.

## Most influential descendants
- K131969: Symbotex (TM) Composite Mesh (2013), 10 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
- K150091: Versatex Monofilament Mesh (2015), 4 descendants of its own
- K220586: Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh (2022), 3 descendants of its own
- K130997: Neoveil (2013), 3 descendants of its own

## Indications for use
The PARIETEXTM composite ventral patch is used for the reinforcement of soft tissues during surgical repair. It is indicated for the treatment of ventral defects (primary and incisional hernias). The three-dimensional non-absorbable monofilament polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

Source page: https://510kreport.com/device/K120506
Methodology: https://510kreport.com/methodology