510(k) · Cleared
ClearedIonics Levante Intervertebral Pillar, Expandable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ionics Medical Corp. · MQP Spinal Vertebral Body Replacement Device
Cleared on Jul 5, 2000 after a 625-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jul 5, 2000
- Review
- 625 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK983667 Ionics Levante Intervertebral Pillar, ExpandableIonics Medical Corp. · 2000
- Descendant · cites it directly · 0 of its ownK081673 Dyn-Alif Anterolateral Intervertebral Body Fusion DeviceIonics Medical Corp. · 2008
Most influential descendants
Showing 1 of 1 · See all- K081673Dyn-Alif Anterolateral Intervertebral Body Fusion DeviceIonics Medical Corp. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983667 | Ionics Levante Intervertebral Pillar, Expandable | Ionics Medical Corp. | 2000 | — |
| +1 | K081673 | Dyn-Alif Anterolateral Intervertebral Body Fusion Device | Ionics Medical Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081673 | Dyn-Alif Anterolateral Intervertebral Body Fusion Device | 2008 | 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, K081673 (Ionics Medical Corp., 2008) has gone furthest, with 0 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 Levante Intervertebral Pillar prosthesis is intended for use in the thoracolumbar spine (i.e., T1 to L35) to replace and to restore the height of a diseased vertebral body resected or excised for the treatment of tumor as well as to concomitantly facilitate anterior decompression of the spinal cord and neural tissues. Two contiguous vertebral bodies are the maximum number of bodies the device is intended to replace. The device is intended to be…
Read the full statement (124 words)
The Levante Intervertebral Pillar prosthesis is intended for use in the thoracolumbar spine (i.e., T1 to L35) to replace and to restore the height of a diseased vertebral body resected or excised for the treatment of tumor as well as to concomitantly facilitate anterior decompression of the spinal cord and neural tissues. Two contiguous vertebral bodies are the maximum number of bodies the device is intended to replace. The device is intended to be always implanted with adjunctive fixation.
To replace a vertebral body for tumor and to replace or restore the height of a vertebral body due to fracture; for example, burst or compression fractures
To facilitate anterior decompression of the spinal cord and neural structure
To facilitate the reduction of kyphotic deformities
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983667 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983667: Ionics Levante Intervertebral Pillar, Expandable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983667
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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