510(k) · Cleared
ClearedEclipse Vertebral Spacer System-Lumbar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apollo Spine, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Jan 12, 2011 after a 167-day review. The FDA summary names no predicate by number.
- Decided
- Jan 12, 2011
- Review
- 167 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
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.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
When used as an Intervertebral Body Fusion System: The Eclipse Vertebral Spacer System-Lumbar is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with accompanying radicular symptoms at one disc level from L2-S1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six…
Read the full statement (170 words)
When used as an Intervertebral Body Fusion System:
The Eclipse Vertebral Spacer System-Lumbar is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with accompanying radicular symptoms at one disc level from L2-S1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Lumbar implants are to be used with autogenous bone graft. Supplemental fixation is required.
When used as a Vertebral Body Replacement Device:
The Eclipse Vertebral Spacer System-Lumbar when used as a vertebral body replacement is intended for use for partial and total replacement of a vertebral body that has been resected or excised due to tumor and/or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine at a single level from T1-L5. These devices are intended to be used with autogenous bone graft. Supplemental fixation is required.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102121: Eclipse Vertebral Spacer System-Lumbar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102121
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026