510(k) · Cleared
ClearedAnova Containment Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anova Corporation · EZX Mesh, Surgical, Metal
Cleared on Aug 13, 2009 as substantially equivalent to K041105 (Macropore Biosurgery, Inc., 2004) and 2 other predicates after a 1,002-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Aug 13, 2009
- Review
- 1,002 days
- Class
- Class II
- Product code
- EZX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K010911 (2001). 7 ancestors in all, the oldest K002063 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK010911 Macropore OS Spinal SystemMacropore Biosurgery, Inc. · 2001
- 2 generations backK021039 Bowti Anterior Buttress Staple SystemDepuyacromed · 2002
- 1 generation backK041105 Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc. · 2004
- This deviceK063461 Anova Containment DeviceAnova Corporation · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010911 | Macropore OS Spinal System | Macropore Biosurgery, Inc. | 2001 | — |
| −2 | K021039 | Bowti Anterior Buttress Staple System | Depuyacromed | 2002 | — |
| −1 | K041105 | Macropore Hydrosorb Spine System | Macropore Biosurgery, Inc. | 2004 | — |
| 0 (this device) | K063461 | Anova Containment Device | Anova Corporation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EZX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041105 | Macropore Hydrosorb Spine SystemSummary page 2…MYSTIQUE T M Resorbable Graft Containment Plating System Manufacturer: MacroPore Biosurgery, Inc. K Number. K041105 Product Code. KWQ Trade Name. OptiMeshTM 1500 Manufacturer. Spineology, Inc. K N… | 2004 |
| * | K014200 | OptimeshSummary page 2…er. K041105 Product Code. KWQ Trade Name. OptiMeshTM 1500 Manufacturer. Spineology, Inc. K Number. K014200 Product Code: EZX Trade Name. Graft Containment Device Manufacturer. NuVasive, Incorpo… | 2003 |
| * | K070148 | Graft Containment Device Cleared while this submission was under review Summary page 2…K014200 Product Code: EZX Trade Name. Graft Containment Device Manufacturer. NuVasive, Incorporated K Number: K070148 Product Code: KWQ Intended Use: The Anova Containment Device, in conjunction with… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K041105.
How does its category compare?
All EZX devicesEZX Mesh, Surgical, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · EZX
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · EZX
Too few EZX 510(k)s in any year since 2007 to give a median.
Recalls per year · EZX
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZX
1in 2025
MAUDE reports naming product code EZX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 0 | — | 0 | 8 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 11 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 1 | 9 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 0 | — | 0 | 25 |
| 2021 | 0 | — | 0 | 35 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063461: Anova Containment Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063461
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026