# K150091: Versatex Monofilament Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Sofradim Production
- Decided: May 26, 2015 after 130 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K991400 (1999). 19 ancestors in all.
4 later devices descend from it; 1 cites 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)
- 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, Sofradim Production (2014) Summary page 4.
- (no number) Mersilene™ Polyester Fiber Mesh: named in the summary without a submission number

## Most influential descendants
- 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
- Mar 15, 2018 · Class II · Z-2427-2018: Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices.
- Feb 23, 2018 · Class II · Z-1523-2018: There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware of risks in

## Indications for use
Versatex™ Monofilament Mesh is intended for the repair of abdominal wail hemias or other fascial deficiencies that require the addition of a reinforcing material.

Source page: https://510kreport.com/device/K150091
Methodology: https://510kreport.com/methodology