# K132025: Meso Bilayer Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corporation Dba Dsm Biomedical
- Decided: Oct 30, 2013 after 121 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: 7 generations back to K921895 (1992). 35 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K094061: Kensey Nash Ecm Surgical Patch, Kensey Nash Corporation (2010) Summary page 2.

## Most influential descendants
- K163217: GORE BIO-A Tissue Reinforcement (2017), 5 descendants of its own
- K232602: 3DMatrix Surgical Mesh (2024), 1 descendant of its own
- K173333: GORE ENFORM Biomaterial (2018), 1 descendant of its own
- K243302: 3DMatrix DynaFlex (DynaFlex) (2025), 0 descendants of its own
- K222919: GORE® ENFORM Biomaterial (2022), 0 descendants of its own

## Indications for use
Mesa Bilayer Surgical Mesh is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair and reinforcement in plastic and reconstructive surgery including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g. hiatal, femoral, paracolostomy, umbilical.) Mesa Bilayer Surgical Mesh is supplied sterile and for one time use.

Source page: https://510kreport.com/device/K132025
Methodology: https://510kreport.com/methodology