510(k) · Cleared
ClearedEclipse Vertebral Spacer System-Cervical
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apollo Spine, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jan 7, 2011 as substantially equivalent to P980048 (Sulzer Spine-Tech, 2001) after a 214-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Jan 7, 2011
- Review
- 214 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P980048 (2001). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K120143Eclipse Vertebral Spacer System-CervicalApollo Spine · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P980048 | Bak/Cervical (Bak/C) Interbody Fusion System | Sulzer Spine-Tech | 2001 | — |
| 0 (this device) | K101588 | Eclipse Vertebral Spacer System-Cervical | Apollo Spine, Inc. | 2011 | — |
| +1 | K120143 | Eclipse Vertebral Spacer System-Cervical | Apollo Spine | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 OVE? 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 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 |
|---|---|---|---|
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…cal Common/Usual Name: Intervertebral body fusion device Classification: 21 CFR §888.3080 Class: il Product Code(s): obDpP Predicate Device(s): o BAK/Cervical (BAK/C®), P980048, Zimmer Spine, Approved 4/20/01 o LDR Spine Cervical Interbody Fusion System, ROI-C, Approved 4/1 5/09 o SpineCraft ORIO-C Inte… | 2001 |
| * | — | LDR Spine Cervical Interbody Fusion System, ROI-C Named without a submission number | |
| * | — | SpineCraft ORIO-C Intervertebral Body Fusion Cervical Cage Named without a submission number |
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 |
|---|---|---|---|
| K120143 | Eclipse Vertebral Spacer System-Cervical | 2012 | 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?
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The Eclipse Vertebral Spacer System-Cervical is indicated for intervertebral body fusion
in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine
with accompanying radicular symptoms at one disc level from C2 to T1. 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-Cervical implants are 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/K101588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101588: Eclipse Vertebral Spacer System-Cervical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101588
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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