# K143380: Phasix ST Mesh

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jun 5, 2015 after 192 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). 20 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070894: Tephaflex Surgical Mesh, Tepha, Inc. (2007) Summary page 4.
- K111946: Tephaflex Mesh, Tepha, Inc. (2011) Summary page 4.
- K113723: Tephaflex Mesh, Tepha, Inc. (2012) Summary page 4.
- K101851: Ventralight ST Mesh, Davol Inc., Sub. C. R. Bard, Inc. (2010) Summary page 4.

## Most influential descendants
- K173143: Phasix ST Mesh (2018), 1 descendant of its own
- K173333: GORE ENFORM Biomaterial (2018), 1 descendant of its own
- K222919: GORE® ENFORM Biomaterial (2022), 0 descendants of its own
- K182008: Phasix ST Mesh with Echo 2 Positioning System (2018), 0 descendants of its own

## Indications for use
The Phasix™ ST Mesh 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.

Source page: https://510kreport.com/device/K143380
Methodology: https://510kreport.com/methodology