510(k) · Cleared
ClearedCOALITION Spacers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jan 29, 2016 as substantially equivalent to K083389 (Globus Medical, Inc., 2009) and 3 other predicates after a 199-day review. Its family tree reaches back 14 generations to 2001. 152 later devices descend from it.
- Decided
- Jan 29, 2016
- Review
- 199 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K003155 (2001). 64 ancestors in all, the oldest K792352 (1979). 152 later devices descend from it, 10 citing it directly.
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations between
- 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK112459 Synthes Zero-PSynthes Spine Co.Lp · 2011
- 1 generation backK131449 Coalition SpacerGlobus Medical, Inc. · 2013
- This deviceK151939 COALITION SpacersGlobus Medical, Inc. · 2016
- Descendant · cites it directly · 83 of its ownK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- Descendant · cites it directly · 83 of its ownK161081 SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2016
- Descendant · cites it directly · 82 of its ownK170569 SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2017
- Descendant · 2 generations on · 74 of its ownK190655 SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2019
- Descendant · 2 generations on · 60 of its ownK183083 Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019
Show all 14 generations
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations backK012254 VBROsteotech, Inc. · 2001
- 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 9 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 5 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 4 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK112459 Synthes Zero-PSynthes Spine Co.Lp · 2011
- 1 generation backK131449 Coalition SpacerGlobus Medical, Inc. · 2013
- This deviceK151939 COALITION SpacersGlobus Medical, Inc. · 2016
Showing 5 of 152 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 152 · See all- K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc. · 2017 · cites it directly83descendants
- K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2016 · cites it directly83descendants
- K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2017 · cites it directly82descendants
- K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 2019 · 2 generations on74descendants
- K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 2019 · 2 generations on60descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −13 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −12 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −9 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −5 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −4 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −3 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −2 | K112459 | Synthes Zero-P | Synthes Spine Co.Lp | 2011 | — |
| −1 | K131449 | Coalition Spacer | Globus Medical, Inc. | 2013 | — |
| 0 (this device) | K151939 | COALITION Spacers | Globus Medical, Inc. | 2016 | — |
| +1 | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS… | Globus Medical, Inc. | 2017 | — |
| +1 | K161081 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | 2016 | — |
| +1 | K170569 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | 2017 | — |
| +2 | K190655 | SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | 2019 | — |
| +2 | K183083 | Shoreline Cervical Interbody RT System | SeaSpine Orthopedics Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 9 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 7 | 0 |
| 2020 | 9 | 0 |
| 2021 | 11 | 0 |
| 2022 | 15 | 0 |
| 2023 | 24 | 0 |
| 2024 | 27 | 0 |
| 2025 | 32 | 0 |
| 2026 | 22 | 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? (4)
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 |
|---|---|---|---|
| * | K083389 | Coalition SpacerSummary page 5…y Fixation Orthosis Product Code(s): OVE, ODP, KWQ Regulatory Class: II, Panel Code: 87 Primary Predicate: COALITION® Spacers (K083389) Additional COALITION® Spacers (K131449) Predicates: LDR Spine ROI-C Implant (K113559) C… | 2009 |
| * | K131449 | Coalition SpacerSummary page 5…de(s): OVE, ODP, KWQ Regulatory Class: II, Panel Code: 87 Primary Predicate: COALITION® Spacers (K083389) Additional COALITION® Spacers (K131449) Predicates: LDR Spine ROI-C Implant (K113559) Centinel Spine STALIF C (K150053) Purpose: The purp… | 2013 |
| * | K113559 | LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsSummary page 5…ass: II, Panel Code: 87 Primary Predicate: COALITION® Spacers (K083389) Additional COALITION® Spacers (K131449) Predicates: LDR Spine ROI-C Implant (K113559) Centinel Spine STALIF C (K150053) Purpose: The purpose of this submission is to request clearance for addi… | 2011 |
| * | K150053 | STALIF C; STALIF C-TiSummary page 5…Spacers (K083389) Additional COALITION® Spacers (K131449) Predicates: LDR Spine ROI-C Implant (K113559) Centinel Spine STALIF C (K150053) Purpose: The purpose of this submission is to request clearance for additional COALITION MIS™ implants; and to update indicatio… | 2015 |
What descends from it? (152)
See all 15210 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and… | 2017 | 83 |
| K161081 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | 2016 | 83 |
| K170569 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | 2017 | 82 |
| K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO… | 2017 | 55 |
| K201073 | Seaspine WaveForm C Interbody System | 2020 | 17 |
| K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA) | 2019 | 10 |
| K211111 | SureMAX-SA Cervical Standalone System | 2021 | 8 |
| K241846 | E3D™-C Interbody System | 2024 | 6 |
| K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) | 2025 | 1 |
| K242517 | ProAM ACDF System | 2024 | 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?
- The line of descent spans 15 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 6 of the 64 ancestors have a recall of any class.
- Of its descendants, K173115 (Globus Medical, Inc., 2017) has gone furthest, with 83 descendants of its own.
- 21 other devices also cite its predicate K083389.
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. 2016, 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?
COALITION® Spacers (including COALITION AGX™ and COALITION MIS™) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. 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…
Read the full statement (357 words)
COALITION® Spacers (including COALITION AGX™ and COALITION MIS™) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. 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. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
The COALITION® Spacer is a stand-alone interbody fusion device intended for use at one or two levels of the cervical spine (C2-T1) and is to be used with two titanium alloy screws which accompany the implant.
The COALITION MIS™ Spacer is an interbody fusion device and is to be used with two titanium alloy screws or anchors which accompany the implants. When used with screws, COALITION MIS™ Spacers are stand-alone interbody fusion devices intended for use at one or two levels of the cervical spine (C2-T1). When used with anchors, COALITION MIS™ Spacers are intended for use at one level of the cervical spine (C2-T1) with additional supplemental fixation such as posterior cervical screw fixation.
The COALITION AGX™ Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When used with the COALITION AGX™ Plate, the plate-spacer assembly takes on the indications for use of the COALITION AGX™ Spacer, with the COALITION AGX™ Plate acting as the supplemental fixation. The COALITION AGX™ Plate and Spacer assembly is a stand-alone device intended for use at one level of the cervical spine (C2-T1) and is to be used with two titanium alloy screws which accompany the implant.
The COALITION AGX™ Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151939: COALITION Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151939
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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