# K991400: Parietene Polypropylene Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Sofradim Production
- Decided: Jul 12, 1999 after 81 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
No predicates in its family tree.
82 later devices descend from it; 8 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bard-Davol Visilex® Mesh: named in the summary without a submission number
- (no number) Atrium Medical Corporation Atrium® Mesh: named in the summary without a submission number
- (no number) Sofradim Parietex® Meshes: named in the summary without a submission number

## Most influential descendants
- K033376: Ugytex Mesh (2004), 70 descendants of its own
- K040998: Modification to Parietex Composite (Pco) Mesh (2004), 61 descendants of its own
- K050187: Parietex Composite Pco-OS and Pco-OB Meshes (2005), 31 descendants of its own
- K073287: Prevadh Mesh (2008), 17 descendants of its own
- K081126: Parietex Composite Mono PM Mesh (2008), 15 descendants of its own

## Indications for use
The Parietene® Polypropylene Mesh is a polypropylene mesh intended for the reinforcement of tissue during surgical repair. It is indicated for inguinal heruiay, puietal reinforcement of tissues and abdominal wall hemia repair.

Source page: https://510kreport.com/device/K991400
Methodology: https://510kreport.com/methodology