# K133223: Xenmatrix AB Surgical Graft

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 19, 2014 after 333 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: 12 generations back to K921895 (1992). 122 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K081272: Porcine Surgical Mesh; Dermal Matrix, Brennen Medical, LLC (2008) Summary page 4.
- K073391: Surgisis Biodesign Tissue Graft, Cook Biotech, Inc. (2008) Summary page 4.
- K113229: Ventrio Light Hernia Patch with TRM Antimicrobial Coating, C.R. Bard, Inc. (2012) Summary page 4.

## Most influential descendants
- K151177: XenMatrix AB Surgical Graft (2015), 1 descendant of its own
- K162193: XenMatrix AB Surgical Graft (2016), 0 descendants of its own

## 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. 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/K133223
Methodology: https://510kreport.com/methodology