# K190185: Phasix ST Mesh with Open Positioning System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jun 12, 2019 after 131 days
- Product code: OWT (Mesh, Surgical, Absorbable, Abdominal Hernia)
- 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: 6 generations back to K971745 (1997). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101920: Ventrio ST Hernia Patch, C.R. Bard, Inc. (2011) Summary page 4.

## Most influential descendants
- K243241: Phasix ST Umbilical Hernia Patch (2025), 0 descendants of its own

## Indications for use
Phasix ST Mesh with Open Positioning System is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias. The open positioning system is intended to facilitate the placement, positioning and fixation of the mesh during open ventral hernia repair.

Source page: https://510kreport.com/device/K190185
Methodology: https://510kreport.com/methodology