510(k) · Cleared

Cleared

Eclipse Vertebral Spacer System-Cervical

K120143510(k) SpecialCleared Feb 16, 201229-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Apollo Spine · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Feb 16, 2012 as substantially equivalent to K101588 (Apollo Spine, Inc., 2011) after a 29-day review. Its family tree reaches back 2 generations to 2001.

Decided: Feb 16, 2012
Review: 29 days
Class: Class II
Product code: ODP
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to P980048 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backP980048 Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 2001
1 generation backK101588 Eclipse Vertebral Spacer System-CervicalApollo Spine, Inc. · 2011
This deviceK120143 Eclipse Vertebral Spacer System-CervicalApollo Spine · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	P980048	Bak/Cervical (Bak/C) Interbody Fusion System	Sulzer Spine-Tech	2001	—
−1	K101588	Eclipse Vertebral Spacer System-Cervical	Apollo Spine, Inc.	2011	—
0 (this device)	K120143	Eclipse Vertebral Spacer System-Cervical	Apollo Spine	2012	—

FIG. 1 — Lineage of K120143, 2001–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 ODP? 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 ODP device

#1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K101588	Eclipse Vertebral Spacer System-Cervical Summary page 2 …on for use and material composition of The Eclipse Vertebral Spacer-Cervical are the same as the currently cleared predicate device, The Eclipse Vertebral Spacer System (K101588). The only difference is the addition of a foot print size with a resulting increase in the graft chamber area: Predicate…	Apollo Spine, Inc.	2011	—

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.

What does this lineage say?

The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2007high 187 (2013) · low 76 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ODP

2in 2025

2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ODP

57in 2025

2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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	0	—	0	0
2008	8	89	0	2
2009	12	127	1	21
2010	9	151	0	54
2011	25	113	1	38
2012	17	93	0	92
2013	18	187	1	78
2014	26	118	0	43
2015	24	180	0	51
2016	17	112	0	37
2017	33	104	0	39
2018	25	133	0	51
2019	22	92	0	141
2020	14	89	1	86
2021	18	121	0	161
2022	12	92	0	50
2023	34	165	0	36
2024	10	76	0	55
2025	11	87	2	57
2026	19	117	0	—

What is it indicated for?

The Eclipse-C Vertebral Spacer System 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-C Vertebral Spacer System implants are to be used with autogenous bone graft. Supplemental fixation is required.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120143 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120143: 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/K120143

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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