# K120728: Phasix Plug and Patch

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 22, 2012 after 227 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: 4 generations back to K002699 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111946: Tephaflex Mesh, Tepha, Inc. (2011)
- K070894: Tephaflex Surgical Mesh, Tepha, Inc. (2007) Summary page 1.
- K092032: Bard Perfix Light Plug, Models 0117050, 0117060, 0117070, 0117080, 0117150, 0117160, Davol Inc., Sub. C. R. Bard, Inc. (2009) Summary page 1.

## Indications for use
The PhasixTM Plug and Patch is indicated for reinforcement of soft tissue, where weakness exists, in procedures involying soft tissue repair, such as groin hernia defects.

Source page: https://510kreport.com/device/K120728
Methodology: https://510kreport.com/methodology