510(k) · Cleared
ClearedSolitaire Anterior Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · MQP Spinal Vertebral Body Replacement Device
Cleared on Oct 17, 2006 after a 28-day review. The FDA summary names its predicate without a number. 1 of the 836 devices in its family, counting itself, has a Class I recall. 835 later devices descend from it.
- Decided
- Oct 17, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 0
835 later devices descend from it, 2 citing it directly. 1 of the 836 devices in this family, counting this one, has a Class I recall.
- This deviceK062810 Solitaire Anterior Spinal SystemEbi, L.P. · 2006
- Descendant · cites it directly · 834 of its ownK081501 Solitaire Anterior Spinal SystemBiomet Spine · 2008 · Recalled
- Descendant · 2 generations on · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- Descendant · 3 generations on · 696 of its ownK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- Descendant · 4 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 5 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
Showing 5 of 835 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 835 · See all- K081501Solitaire Anterior Spinal SystemBiomet Spine · 2008 · cites it directly834descendants
- K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · 2 generations on744descendants
- K123045Brigade Standalone SystemNuvasive, Inc. · 2013 · 3 generations on696descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 4 generations on588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 5 generations on479descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062810 | Solitaire Anterior Spinal System | Ebi, L.P. | 2006 | — |
| +1 | K081501 | Solitaire Anterior Spinal System | Biomet Spine | 2008 | 1 |
| +2 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| +3 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| +4 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +5 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 12 | 0 |
| 2015 | 24 | 0 |
| 2016 | 43 | 0 |
| 2017 | 54 | 0 |
| 2018 | 63 | 0 |
| 2019 | 70 | 0 |
| 2020 | 91 | 0 |
| 2021 | 70 | 1 |
| 2022 | 72 | 0 |
| 2023 | 85 | 0 |
| 2024 | 92 | 0 |
| 2025 | 76 | 0 |
| 2026 | 66 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | — | Interpore Cross International Anterior Fixation Device (AFD) Named without a submission number | |
| * | — | Interpore Cross International Expandable PEEK VBR System Named without a submission number | |
| * | — | EBI ESL Spine Spacer System Named without a submission number |
What descends from it? (835)
See all 8352 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K081501 (Biomet Spine, 2008) has gone furthest, with 834 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 Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., TIO to LS) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neugal tissues, and to restore the height of a collapsed vertebral body. The Solitaire System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062810 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062810: Solitaire Anterior Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062810
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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