# K142818: Phasix Mesh

- Pathway: 510(k) (Traditional)
- Applicant: C. R. Bard
- Decided: Mar 31, 2015 after 183 days
- Product code: OOD (Surgical Film)
- 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: 4 generations back to K002699 (2001). 12 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113723: Tephaflex Mesh, Tepha, Inc. (2012) Summary page 4.
- K111946: Tephaflex Mesh, Tepha, Inc. (2011) Summary page 4.
- K070894: Tephaflex Surgical Mesh, Tepha, Inc. (2007) Summary page 4.

## Most influential descendants
- K161424: Phasix Mesh (2016), 2 descendants of its own
- K191749: TIGR Matrix Surgical Mesh, TIGR Surgical Mesh (2020), 1 descendant of its own
- K233661: Transorb™ Self-Gripping Resorbable Mesh (2024), 0 descendants of its own

## Indications for use
The Phasix™ Mesh is indicated to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Source page: https://510kreport.com/device/K142818
Methodology: https://510kreport.com/methodology