# K243241: Phasix ST Umbilical Hernia Patch

- Pathway: 510(k) (Traditional)
- Applicant: Davol, Inc., A Subsidiary of C.R. Bard, Inc.
- Decided: Feb 19, 2025 after 132 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: 7 generations back to K971745 (1997). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101928: Ventralex ST Hernia Patch, C.R. Bard, Inc. (2011) Summary page 5.
- K190185: Phasix ST Mesh with Open Positioning System, C.R. Bard, Inc. (2019) Summary page 6.

## Indications for use
Phasix™ ST Umbilical Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving the repair of umbilical hernias.

Source page: https://510kreport.com/device/K243241
Methodology: https://510kreport.com/methodology