# K161424: Phasix Mesh

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 29, 2016 after 129 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: 5 generations back to K002699 (2001). 13 ancestors in all.
2 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)
- K142818: Phasix Mesh, C. R. Bard (2015) Summary page 4.

## Most influential descendants
- 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
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/K161424
Methodology: https://510kreport.com/methodology