# K140501: Xenmatrix Surgical Graft

- Pathway: 510(k) (Special)
- Applicant: C. R. Bard
- Decided: Apr 28, 2014 after 60 days
- Product code: FTM (Mesh, Surgical)
- 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: 10 generations back to K921895 (1992). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081272: Porcine Surgical Mesh; Dermal Matrix, Brennen Medical, LLC (2008) Summary page 1.

## Indications for use
Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.

Source page: https://510kreport.com/device/K140501
Methodology: https://510kreport.com/methodology