# K020853: Nuvasive Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Jun 13, 2002 after 90 days
- Product code: EZX (Mesh, Surgical, Metal)
- 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: 2 generations back to K900138 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983766: Synthes Synmesh, Synthes (Usa) (1998) Summary page 1.
- K900138: Motech Titanium Surgical Mesh, Biedermann Motech GmbH (1990) Summary page 1.
- K974017: Timesh System, Sofamor Danek USA,Inc. (1998) Summary page 1.
- K973145: Timesh Titanium Mini-Softplate and Micro-Soft Plate/Screw System, Sofamor Danek USA,Inc. (1997) Summary page 1.

## Indications for use
The Nu Vasive® Mesh is indicated for use in the reinforcement of weak bony tissue in orthopedic procedures.

Source page: https://510kreport.com/device/K020853
Methodology: https://510kreport.com/methodology