# K110815: Parietex Optimized Compostie Mesh

- Pathway: 510(k) (Special)
- Applicant: Sofradim Production
- Decided: Apr 19, 2011 after 26 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: 3 generations back to K991400 (1999). 5 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002699: Parietex Composite (Pco) Mesh, Medical Device Consultants, Inc. (2001) Summary page 2.
- K040998: Modification to Parietex Composite (Pco) Mesh, Sofradim Production (2004) Summary page 1.

## Most influential descendants
- K173796: Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) (2018), 4 descendants of its own
- K220586: Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh (2022), 3 descendants of its own
- K232373: Progrip™ Self-Gripping Polypropylene Mesh (2024), 2 descendants of its own
- K243315: ProGrip™ Self-Gripping Polypropylene Mesh (2025), 1 descendant of its own
- K253956: ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) (2026), 0 descendants of its own

## Indications for use
The PARIETEX TM Optimized Composite mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

Source page: https://510kreport.com/device/K110815
Methodology: https://510kreport.com/methodology