# K081050: Parietex Progrip Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Sofradim Production
- Decided: May 28, 2008 after 44 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). 10 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982532: Parietex, Cogent (1999) Summary page 1.
- K003990: Sofradim Parietex Surgical Meshes, Sofradim Production (2001) Summary page 1.
- K073287: Prevadh Mesh, Sofradim Production (2008) Summary page 1.
- K930591: TI-Cron and Dacron Sutures, Davis & Geck, Inc. (1993) Summary page 1.

## Most influential descendants
- K103682: Parietex Progrip (2011), 6 descendants of its own
- K101519: Parietex Plug and Patch (2010), 6 descendants of its own
- K101197: Parie Tene Progrip Mesh (2010), 6 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
- K140941: Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet Mesh (2014), 5 descendants of its own

## Indications for use
PARIETEX TM PROGRIP TM Mesh is indicated for inguinal and incisional hernia repair.

Source page: https://510kreport.com/device/K081050
Methodology: https://510kreport.com/methodology