# K050187: Parietex Composite Pco-OS and Pco-OB Meshes

- Pathway: 510(k) (Special)
- Applicant: Sofradim Production
- Decided: Feb 18, 2005 after 22 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). 6 ancestors in all.
31 later devices descend from it; 3 cite it directly.
0 of 38 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 1.
- K040998: Modification to Parietex Composite (Pco) Mesh, Sofradim Production (2004) Summary page 1.
- K003323: Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205, Davol, Inc. (2001) Summary page 1.

## Most influential descendants
- K062915: Veritas Collagen Matrix (2006), 15 descendants of its own
- K110816: Parietex Optimized Composite Mesh (Pco-Osx References) (2011), 14 descendants of its own
- K131969: Symbotex (TM) Composite Mesh (2013), 10 descendants of its own
- K073391: Surgisis Biodesign Tissue Graft (2008), 8 descendants of its own
- K142908: Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh (2014), 5 descendants of its own

## Indications for use
The PCO-OS and PCO-OB meshes are used for the reinforcement of tissues during surgical repair. They are indicated for the treatment of incisional hernias, abdominal wall repair, and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-resorbable polyester mesh provides long-term reinforcement of soft tissues. On the opposite side, the resorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

Source page: https://510kreport.com/device/K050187
Methodology: https://510kreport.com/methodology