# K142091: Parietene Macroporous Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Sofradim Production
- Decided: Oct 17, 2014 after 77 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: 7 generations back to K991400 (1999). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001122: Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh, ETHICON, Inc. (2000) Summary page 4.
- K140941: Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet Mesh, Sofradim Production (2014) Summary page 4.

## Most influential descendants
- K223218: Parietene Macroporous Mesh (2022), 1 descendant of its own
- K250869: Parietene™ Macroporous Mesh  (PPM5050 ) (2025), 0 descendants of its own

## Indications for use
The Parietene™ Macroporous Mesh is intended for the repair of hernias or other fascial deficiencies that require the addition of a reinforcing material.

Source page: https://510kreport.com/device/K142091
Methodology: https://510kreport.com/methodology