# 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

- Pathway: 510(k) (Special)
- Applicant: Sofradim Production
- Decided: Nov 14, 2014 after 39 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K991400 (1999). 18 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090858: Parietex Monofilament Polyester Mesh, Sofradim Production (2009) Summary page 8.
- K081126: Parietex Composite Mono PM Mesh, Sofradim Production (2008) Summary page 8.
- K120506: Parietex Composite Ventral Patch, Sofradim Production (2012) Summary page 8.
- K131969: Symbotex (TM) Composite Mesh, Sofradim Production (2013) Summary page 8.

## Most influential descendants
- K150091: Versatex Monofilament Mesh (2015), 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

## Recalls of this device
- Oct 5, 2018 · Class II · Z-0461-2019: The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair tech

## Indications for use
Parietex™ lightweight mesh is indicated for inguinal and ventral hernia repair. The PARIETEX™ Parastomal Mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The non-absorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera. The Parietex™ composite ventral patch is used for the reinforcement of soft tissues during surgical repair. It is indicated for the treatment of ventral defects (primary and incisional hernias). The three-dimensional non-absorbable monofilament polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera. Symbotex™ composite mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists in procedures involving primary abdominal wall and incisional hernia surgeries. 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/K142908
Methodology: https://510kreport.com/methodology