# K243315: ProGrip™ Self-Gripping Polypropylene Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Sofradim Production
- Decided: Jan 17, 2025 after 87 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: 10 generations back to K991400 (1999). 36 ancestors in all.
1 later device descends from it; 1 cites 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)
- K232373: Progrip™ Self-Gripping Polypropylene Mesh, Sofradim Production (2024) Summary page 5.

## Most influential descendants
- K253956: ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) (2026), 0 descendants of its own

## Indications for use
ProGrip TM self-gripping polypropylene mesh is intenided for use in reinforcement of abdominal wall soft tissue where weakness exists. The ProGrip ™ self-gripping polypropylene mesh rectangular and square shapes are indicated for inguinal and ventral hernia repair.

Source page: https://510kreport.com/device/K243315
Methodology: https://510kreport.com/methodology