# K063461: Anova Containment Device

- Pathway: 510(k) (Traditional)
- Applicant: Anova Corporation
- Decided: Aug 13, 2009 after 1,002 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: 3 generations back to K010911 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041105: Macropore Hydrosorb Spine System, Macropore Biosurgery, Inc. (2004) Summary page 2.
- K014200: Optimesh, Spineology, Inc. (2003) Summary page 2.
- K070148: Graft Containment Device, Nuvasive, Inc. (2007). Cleared while this submission was under review Summary page 2.

## Indications for use
The Anova Containment Device, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

Source page: https://510kreport.com/device/K063461
Methodology: https://510kreport.com/methodology