# K253956: ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)

- Pathway: 510(k) (Traditional)
- Applicant: Sofradim Production
- Decided: May 21, 2026 after 162 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: 11 generations back to K991400 (1999). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243315: ProGrip™ Self-Gripping Polypropylene Mesh, Sofradim Production (2025) Summary page 5.

## Indications for use
ProGrip™ advanced self-gripping polypropylene mesh is intended for use in reinforcement of abdominal wall soft tissues where weakness exists. It is indicated for use in the extraperitoneal space during ventral hernia repair procedures, utilizing either conventional laparoscopic or robotic-assisted surgical techniques.

Source page: https://510kreport.com/device/K253956
Methodology: https://510kreport.com/methodology