# K151177: XenMatrix AB Surgical Graft

- Pathway: 510(k) (Traditional)
- Applicant: C. R. Bard
- Decided: Jul 30, 2015 after 90 days
- Product code: PIJ (Collagen Surgical Mesh Containing Drugs)
- 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: 13 generations back to K921895 (1992). 123 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133223: Xenmatrix AB Surgical Graft, C.R. Bard, Inc. (2014) Summary page 4.

## Most influential descendants
- K162193: XenMatrix AB Surgical Graft (2016), 0 descendants of its own

## Indications for use
The XenMatrix™ AB Surgical Graft is 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. The Rifampin and Minocycline coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization on the device. The claim of reduction of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated.

Source page: https://510kreport.com/device/K151177
Methodology: https://510kreport.com/methodology