# K101197: Parie Tene Progrip Mesh

- Pathway: 510(k) (Special)
- Applicant: Sofradim Production
- Decided: May 5, 2010 after 7 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). 11 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081050: Parietex Progrip Mesh, Sofradim Production (2008) Summary page 1.
- K991400: Parietene Polypropylene Mesh, Sofradim Production (1999) Summary page 1.
- K003990: Sofradim Parietex Surgical Meshes, Sofradim Production (2001) Summary page 1.

## Most influential descendants
- K140941: Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet Mesh (2014), 5 descendants of its own
- K142091: Parietene Macroporous Mesh (2014), 2 descendants of its own
- K223218: Parietene Macroporous Mesh (2022), 1 descendant of its own
- K253125: Parietene™ Flat Sheet Mesh (2025), 0 descendants of its own
- K250869: Parietene™ Macroporous Mesh  (PPM5050 ) (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K101197
Methodology: https://510kreport.com/methodology