510(k) · Cleared
ClearedNuvasive Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Nov 13, 2003 after a 93-day review. The FDA summary names its predicate without a number. 753 later devices descend from it.
- Decided
- Nov 13, 2003
- Review
- 93 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 0
753 later devices descend from it, 6 citing it directly.
- This deviceK032476 Nuvasive MeshNuvasive, Inc. · 2003
- Descendant · cites it directly · 712 of its ownK043405 Nuvasive Coroent SystemNuvasive, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 666 of its ownK051454 Aleutian Spacer SystemK2m, LLC · 2005
- Descendant · 3 generations on · 663 of its ownK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- Descendant · 3 generations on · 662 of its ownK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- Descendant · 4 generations on · 595 of its ownK101302 Aleutian Ibf SystemK2m, Inc. · 2010
Showing 5 of 753 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 753 · See all- K043405Nuvasive Coroent SystemNuvasive, Inc. · 2005 · cites it directly712descendants
- K051454Aleutian Spacer SystemK2m, LLC · 2005 · 2 generations on666descendants
- K063399Aleutian Spacer SystemK2m, Inc. · 2007 · 3 generations on663descendants
- K082698Aleutian Ibf SystemK2m, Inc. · 2009 · 3 generations on662descendants
- K101302Aleutian Ibf SystemK2m, Inc. · 2010 · 4 generations on595descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032476 | Nuvasive Mesh | Nuvasive, Inc. | 2003 | — |
| +1 | K043405 | Nuvasive Coroent System | Nuvasive, Inc. | 2005 | 1 |
| +2 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| +3 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| +3 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| +4 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 9 | 0 |
| 2013 | 13 | 0 |
| 2014 | 15 | 0 |
| 2015 | 24 | 0 |
| 2016 | 19 | 0 |
| 2017 | 44 | 0 |
| 2018 | 57 | 0 |
| 2019 | 58 | 0 |
| 2020 | 63 | 0 |
| 2021 | 62 | 0 |
| 2022 | 74 | 0 |
| 2023 | 87 | 0 |
| 2024 | 87 | 0 |
| 2025 | 66 | 0 |
| 2026 | 60 | 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 MQP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | NuVasive Mesh Named without a submission number |
What descends from it? (753)
See all 7536 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043405 | Nuvasive Coroent System | 2005 | 712 |
| K142205 | NuVasive X-CORE (R) Expandable VBR System | 2015 | 74 |
| K131724 | Pioneer Maxfuse Vertebral Body Replacement Device | 2013 | 73 |
| K151538 | NuVasive PEEK Corpectomy Railed System | 2015 | 13 |
| K151167 | NuVasive PEEK Corpectomy System | 2015 | 13 |
| K140563 | Lateral VBR System | 2014 | 0 |
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?
- Of its descendants, K043405 (Nuvasive, Inc., 2005) has gone furthest, with 712 descendants of its own.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The NuVasive' Mesh is a vertebral body replacement device indicated for use in the
thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by
tumor or fracture, to restore height of a collapsed vertebral body, and to achieve
decompression of the spinal cord and neural tissues. The NuVasiveO Mesh is intended to
be used with supplemental internal spinal fixation systems that are cleared by the FDA for
use in the thoracic and lumbar spine. Allograft or autograft material may be used at the
surgeon's discretion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032476 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032476: Nuvasive Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032476
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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