# K072951: Parietene Duo and Quadra Polypropylene Meshes

- Pathway: 510(k) (Special)
- Applicant: Sofradim Production
- Decided: Dec 19, 2007 after 62 days
- Product code: OTP (Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed)
- Device class: 3
- Regulation: 21 CFR 884.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K991400 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051503: Ugytex Sual Knit Mesh, Sofradim Production (2005) Summary page 1.
- K991400: Parietene Polypropylene Mesh, Sofradim Production (1999). Our OCR of the scanned summary read K891400, FDA’s number for Micro Cautery Needles (Zinnanti Surgical Instruments, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Parietene™ Polypropylene Mesh”.

## Indications for use
Parietene™ Duo and Parietene™ Quadra Polypropylene Meshes are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.

Source page: https://510kreport.com/device/K072951
Methodology: https://510kreport.com/methodology