510(k) · Cleared

Cleared

Coalition Spacer

K083389510(k) SpecialCleared Mar 26, 2009129-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

Globus Medical, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

Cleared on Mar 26, 2009 as substantially equivalent to K072991 (Globus Medical, Inc., 2008) after a 129-day review. Its family tree reaches back 1 generation to 2008. 1 of the 635 devices in its family, counting itself, has a Class I recall. 633 later devices descend from it.

Decided: Mar 26, 2009
Review: 129 days
Class: Class II
Product code: OVE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K072991 (2008). 633 later devices descend from it, 22 citing it directly. 1 of the 635 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK072991 Patriot Spacers: Colonial AcdfGlobus Medical, Inc. · 2008
This deviceK083389 Coalition SpacerGlobus Medical, Inc. · 2009
Descendant · cites it directly · 405 of its ownK122630 IN:C2 Spinal Fixation SystemSpine Smith Partners L.P. · 2012
Descendant · cites it directly · 345 of its ownK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
Descendant · 2 generations on · 330 of its ownK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
Descendant · 3 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
Descendant · cites it directly · 281 of its ownK132999 Cervical Stand Alone SystemOrthofix, Inc. · 2014

Showing 5 of 633 descendants. See all descendants

Descendants cleared per year

2010high 74 (2023) · low 1 (2010)2026

Class I recalls in this family

K211616 ExcelsiusHub3 generations on · 2021

Most influential descendants

Showing 5 of 633 · See all

K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P. · 2012 · cites it directly405descendants
K111439Chesapeake (Cervical Components)K2m, Inc. · 2011 · cites it directly345descendants
K133494Chesapeake Spinal SystemK2m, Inc. · 2014 · 2 generations on330descendants
K160125Cascadia Interbody SystemK2m · 2016 · 3 generations on315descendants
K132999Cervical Stand Alone SystemOrthofix, Inc. · 2014 · cites it directly281descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K072991	Patriot Spacers: Colonial Acdf	Globus Medical, Inc.	2008	—
0 (this device)	K083389	Coalition Spacer	Globus Medical, Inc.	2009	—
+1	K122630	IN:C2 Spinal Fixation System	Spine Smith Partners L.P.	2012	—
+1	K111439	Chesapeake (Cervical Components)	K2m, Inc.	2011	1
+2	K133494	Chesapeake Spinal System	K2m, Inc.	2014	—
+3	K160125	Cascadia Interbody System	K2m	2016	—
+1	K132999	Cervical Stand Alone System	Orthofix, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	4	0
2012	6	0
2013	7	0
2014	9	0
2015	21	0
2016	21	0
2017	45	0
2018	34	0
2019	44	0
2020	57	0
2021	53	1
2022	61	0
2023	74	0
2024	69	0
2025	65	0
2026	62	0

FIG. 1 — Lineage of K083389, 2008–2026Source: 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.

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 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

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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
*	K072991	Patriot Spacers: Colonial Acdf Summary page 1 …N™ Spacer Ciassification: Product Code ODP. Class II. 21 CFR §888.3080 Intervertebral body fusion device. Predicate(s): PATRIOT™ Cervical Spacer (Colonia™ ACDF Spacer) K072991 and other legally marketed devices. Device Description: The COALITION™ Spacer is a stand-alone cervical interbody fusion device…	Globus Medical, Inc.	2008	—

Also cleared against K072991: 10 other devices →

What descends from it? (633)

See all 633

22 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K122630	IN:C2 Spinal Fixation System	Spine Smith Partners L.P.	2012	405
K111439	Chesapeake (Cervical Components)	K2m, Inc.	2011	345
K132999	Cervical Stand Alone System	Orthofix, Inc.	2014	281
K130478	Sustain and Sustain Radiolucent Spacers	Globus Medical, Inc.	2013	256
K131449	Coalition Spacer	Globus Medical, Inc.	2013	235
K143578	SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…	Globus Medical, Inc.	2016	210
K142218	Coalition AGX Plate and Coalition AGX Spacer	Globus Medical, Inc.	2015	155
K151939	COALITION Spacers	Globus Medical, Inc.	2016	152
K152022	SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…	Globus Medical, Inc.	2017	149
K122771	Spinal Elements Cervical Intervertebral Body Fusion System	Spinal Elements, Inc.	2013	147

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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K122630 (Spine Smith Partners L.P., 2012) has gone furthest, with 405 descendants of its own.
10 other devices also cite its predicate K072991.

How does its category compare?

All OVE devices

OVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · OVE

10in 2025

2007high 16 (2023) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVE

105in 2025

2007high 210 (2010) · low 56 (2024)2026

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

Recalls per year · OVE

2in 2021

2007high 2 (2021) · low 0 (2007)2026

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

Adverse event reports per year · OVE

132in 2025

2007high 250 (2013) · low 0 (2007)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 COALITION™ Spacer is a stand-alone interbody fusion device mtended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The COALITION™ Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant.

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/K083389 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083389: Coalition Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083389

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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