510(k) · Cleared
ClearedCoalition AGX Plate and Coalition AGX Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Mar 31, 2015 as substantially equivalent to K130478 (Globus Medical, Inc., 2013) and 6 other predicates after a 231-day review. Its family tree reaches back 12 generations to 2001. 155 later devices descend from it.
- Decided
- Mar 31, 2015
- Review
- 231 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 12 generations to K003155 (2001). 81 ancestors in all, the oldest K792352 (1979). 155 later devices descend from it, 9 citing it directly.
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 8 generations between
- 3 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 2 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 1 generation backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- This deviceK142218 Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015
- Descendant · cites it directly · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
- Descendant · 2 generations on · 97 of its ownK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
- Descendant · 3 generations on · 84 of its ownK191391 HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
- Descendant · cites it directly · 83 of its ownK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- Descendant · 3 generations on · 37 of its ownK192115 SABLE Expandable SpacerGlobus Medical, Inc. · 2020
Show all 12 generations
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations backK012254 VBROsteotech, Inc. · 2001
- 10 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 8 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 7 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 4 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 3 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 2 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 1 generation backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- This deviceK142218 Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015
Showing 5 of 155 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 155 · See all- K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · cites it directly149descendants
- K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018 · 2 generations on97descendants
- K191391HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019 · 3 generations on84descendants
- K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc. · 2017 · cites it directly83descendants
- K192115SABLE Expandable SpacerGlobus Medical, Inc. · 2020 · 3 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −11 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −10 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −8 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −7 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −4 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −3 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −2 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −1 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| 0 (this device) | K142218 | Coalition AGX Plate and Coalition AGX Spacer | Globus Medical, Inc. | 2015 | — |
| +1 | K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers… | Globus Medical, Inc. | 2017 | — |
| +2 | K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | Globus Medical, Inc. | 2018 | — |
| +3 | K191391 | HEDRON Lumbar Spacers | Globus Medical, Inc. | 2019 | — |
| +1 | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS… | Globus Medical, Inc. | 2017 | — |
| +3 | K192115 | SABLE Expandable Spacer | Globus Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 4 | 0 |
| 2003 | 11 | 0 |
| 2004 | 12 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 8 | 0 |
| 2009 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 8 | 0 |
| 2021 | 12 | 0 |
| 2022 | 18 | 0 |
| 2023 | 22 | 0 |
| 2024 | 32 | 0 |
| 2025 | 31 | 0 |
| 2026 | 21 | 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 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
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K130478 | Sustain and Sustain Radiolucent SpacersSummary page 4…: Il; Panel Code: 87 21CFR §888.3060 Spinal Intervertebral Body Fixation Orthosis Product Code: KWQ Regulatory Class: II; Panel Code: 87 SUSTAIN® Radiolucent Medium (K130478) VIP® Anterior Cervical Plate System (K081391) InterPlate™ C (K092070) IN:C2™ Spinal Fixation System (K122630) PEEK Prevail® C… | 2013 |
| * | K081391 | Vip Anterior Cervical Plate SystemSummary page 4…tervertebral Body Fixation Orthosis Product Code: KWQ Regulatory Class: II; Panel Code: 87 SUSTAIN® Radiolucent Medium (K130478) VIP® Anterior Cervical Plate System (K081391) InterPlate™ C (K092070) IN:C2™ Spinal Fixation System (K122630) PEEK Prevail® Cervical Interbody Device (K073285) PATRIOT® Col… | 2008 |
| * | K092070 | Interplate CSummary page 4…on Orthosis Product Code: KWQ Regulatory Class: II; Panel Code: 87 SUSTAIN® Radiolucent Medium (K130478) VIP® Anterior Cervical Plate System (K081391) InterPlate™ C (K092070) IN:C2™ Spinal Fixation System (K122630) PEEK Prevail® Cervical Interbody Device (K073285) PATRIOT® Colonial® ACDF Spacer (K072… | 2009 |
| * | K122630 | IN:C2 Spinal Fixation SystemSummary page 4…y Class: II; Panel Code: 87 SUSTAIN® Radiolucent Medium (K130478) VIP® Anterior Cervical Plate System (K081391) InterPlate™ C (K092070) IN:C2™ Spinal Fixation System (K122630) PEEK Prevail® Cervical Interbody Device (K073285) PATRIOT® Colonial® ACDF Spacer (K072991) COALITION® Spacer (K083389) The pur… | 2012 |
| * | K073285 | Peek Prevail Cervical Interbody DeviceSummary page 4…edium (K130478) VIP® Anterior Cervical Plate System (K081391) InterPlate™ C (K092070) IN:C2™ Spinal Fixation System (K122630) PEEK Prevail® Cervical Interbody Device (K073285) PATRIOT® Colonial® ACDF Spacer (K072991) COALITION® Spacer (K083389) The purpose of this submission is to request clearance for… | 2008 |
| * | K072991 | Patriot Spacers: Colonial AcdfSummary page 4…late System (K081391) InterPlate™ C (K092070) IN:C2™ Spinal Fixation System (K122630) PEEK Prevail® Cervical Interbody Device (K073285) PATRIOT® Colonial® ACDF Spacer (K072991) COALITION® Spacer (K083389) The purpose of this submission is to request clearance for the COALITION AGX™ Plate and COALITION A… | 2008 |
| * | K083389 | Coalition SpacerSummary page 4…late™ C (K092070) IN:C2™ Spinal Fixation System (K122630) PEEK Prevail® Cervical Interbody Device (K073285) PATRIOT® Colonial® ACDF Spacer (K072991) COALITION® Spacer (K083389) The purpose of this submission is to request clearance for the COALITION AGX™ Plate and COALITION AGX™ Spacer. Device Descript… | 2009 |
What descends from it? (155)
See all 1559 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®… | 2017 | 149 |
| K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and… | 2017 | 83 |
| K191243 | HEDRON Cervical Spacers | 2019 | 36 |
| K152793 | Unison-C Anterior Cervical Fixation System | 2016 | 29 |
| K190885 | Elevation Spine Saber-C System | 2019 | 25 |
| K221049 | Zavation VariSync Plate System and VariSync Spacer System | 2022 | 6 |
| K250764 | SpineLinc Anterior Cervical Implant System | 2025 | 0 |
| K250769 | Dakota LP System | 2025 | 0 |
| K220334 | MONET Anterior Cervical Plate System | 2022 | 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 14 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 4 of the 81 ancestors have a recall of any class.
- Of its descendants, K152022 (Globus Medical, Inc., 2017) has gone furthest, with 149 descendants of its own.
- 11 other devices also cite its predicate K130478.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 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 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), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.…
Read the full statement (193 words)
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), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The COALITION AGX™ Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-TI) 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 AGX™ Spacer is to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation such as the COALITION AGX™ Plate, ASSURE®, PROVIDENCE™, VIP®, XTEND®, or UNIFY™ Anterior Cervical Plate Systems. When used with the COALITION AGX™ Plate, the assembly takes on the indications for use of the COALITION AGX™ Spacer, with the COALITION AGX™ Plate acting as the supplemental fixation.
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/K142218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142218: Coalition AGX Plate and Coalition AGX Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142218
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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