# K101519: Parietex Plug and Patch

- Pathway: 510(k) (Traditional)
- Applicant: Sofradim Production
- Decided: Nov 5, 2010 after 156 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: 5 generations back to K991400 (1999). 14 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K922916: Bard Marlex Mesh Dart, C.R. Bard, Inc. (1992) Summary page 1.
- K081050: Parietex Progrip Mesh, Sofradim Production (2008) Summary page 1.
- K090858: Parietex Monofilament Polyester Mesh, Sofradim Production (2009) Summary page 1.
- K081126: Parietex Composite Mono PM Mesh, Sofradim Production (2008) Summary page 1.

## Most influential descendants
- 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
- 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

## Indications for use
PARIETEX Plug and Patch is indicated for the reinforcement of soft tissues during repair of groin hernia defects by open approach.

Source page: https://510kreport.com/device/K101519
Methodology: https://510kreport.com/methodology