510(k) · Cleared
ClearedCOALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS
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 Dec 20, 2017 as substantially equivalent to K152022 (Globus Medical, Inc., 2017) and 5 other predicates after an 82-day review. Its family tree reaches back 16 generations to 1984. 83 later devices descend from it.
- Decided
- Dec 20, 2017
- Review
- 82 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 16 generations to K841189 (1984). 213 ancestors in all, the oldest K792352 (1979). 83 later devices descend from it, 12 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- 2 generations backK142299 CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014
- 1 generation backK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
- This deviceK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
- Descendant · cites it directly · 37 of its ownK180909 REVEL SpacersGlobus Medical, Inc. · 2018
- Descendant · cites it directly · 36 of its ownK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019
- Descendant · cites it directly · 25 of its ownK200087 F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020
- Descendant · cites it directly · 25 of its ownK190885 Elevation Spine Saber-C SystemElevation Spine · 2019
- Descendant · 2 generations on · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 6 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 5 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 4 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 3 generations backK102547 Coroent Interlock SystemNuvasive, Inc. · 2011
- 2 generations backK142299 CoRoent Small Interlock SystemNu Vasive, Incorporated · 2014
- 1 generation backK161442 NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated · 2016
- This deviceK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- K180909REVEL SpacersGlobus Medical, Inc. · 2018 · cites it directly37descendants
- K191243HEDRON Cervical SpacersGlobus Medical, Inc. · 2019 · cites it directly36descendants
- K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020 · cites it directly25descendants
- K190885Elevation Spine Saber-C SystemElevation Spine · 2019 · cites it directly25descendants
- K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · 2 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −6 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −5 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −4 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −3 | K102547 | Coroent Interlock System | Nuvasive, Inc. | 2011 | — |
| −2 | K142299 | CoRoent Small Interlock System | Nu Vasive, Incorporated | 2014 | — |
| −1 | K161442 | NuVasive® CoRoent® Small Interlock™ System | Nu Vasive, Incorporated | 2016 | — |
| 0 (this device) | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS… | Globus Medical, Inc. | 2017 | — |
| +1 | K180909 | REVEL Spacers | Globus Medical, Inc. | 2018 | — |
| +1 | K191243 | HEDRON Cervical Spacers | Globus Medical, Inc. | 2019 | — |
| +1 | K200087 | F3D Cervical Stand-Alone Interbody Fusion System | Corelink, LLC | 2020 | — |
| +1 | K190885 | Elevation Spine Saber-C System | Elevation Spine | 2019 | — |
| +2 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer… | Globus Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 11 | 0 |
| 2002 | 9 | 0 |
| 2003 | 13 | 0 |
| 2004 | 24 | 0 |
| 2005 | 14 | 0 |
| 2006 | 10 | 0 |
| 2007 | 12 | 0 |
| 2008 | 24 | 0 |
| 2009 | 14 | 0 |
| 2010 | 6 | 0 |
| 2011 | 9 | 0 |
| 2012 | 8 | 0 |
| 2013 | 8 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 14 | 0 |
| 2025 | 23 | 0 |
| 2026 | 16 | 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? (6)
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 |
|---|---|---|---|
| * | K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Summary page 5…Body Fixation Orthosis Product Code(s): ODP, OVE, KWQ Regulatory Class: II, Panel Code: 87 Primary Predicate: COALITION® Spacer (K152022) Additional COALITION MIS® (K151939) Predicates: COALITION® TPS (K143578) COALITION AGX® (K… | 2017 |
| * | K151939 | COALITION SpacersSummary page 5…duct Code(s): ODP, OVE, KWQ Regulatory Class: II, Panel Code: 87 Primary Predicate: COALITION® Spacer (K152022) Additional COALITION MIS® (K151939) Predicates: COALITION® TPS (K143578) COALITION AGX® (K142218) NuVasive CoRoent S… | 2016 |
| * | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Summary page 5…Regulatory Class: II, Panel Code: 87 Primary Predicate: COALITION® Spacer (K152022) Additional COALITION MIS® (K151939) Predicates: COALITION® TPS (K143578) COALITION AGX® (K142218) NuVasive CoRoent Small Interlock (K161442)… | 2016 |
| * | K142218 | Coalition AGX Plate and Coalition AGX SpacerSummary page 5…ary Predicate: COALITION® Spacer (K152022) Additional COALITION MIS® (K151939) Predicates: COALITION® TPS (K143578) COALITION AGX® (K142218) NuVasive CoRoent Small Interlock (K161442) NuVasive CoRoent Small Interbody (K163491) P… | 2015 |
| * | K161442 | NuVasive® CoRoent® Small Interlock™ SystemSummary page 5…COALITION MIS® (K151939) Predicates: COALITION® TPS (K143578) COALITION AGX® (K142218) NuVasive CoRoent Small Interlock (K161442) NuVasive CoRoent Small Interbody (K163491) Purpose: The purpose of this submission is to request clearance… | 2016 |
| * | K163491 | NuVasive CoRoent Small Interbody SystemSummary page 5…143578) COALITION AGX® (K142218) NuVasive CoRoent Small Interlock (K161442) NuVasive CoRoent Small Interbody (K163491) Purpose: The purpose of this submission is to request clearance for additional implants and indications for the COALITION® Spac… | 2017 |
What descends from it? (83)
See all 8312 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180909 | REVEL Spacers | 2018 | 37 |
| K191243 | HEDRON Cervical Spacers | 2019 | 36 |
| K200087 | F3D Cervical Stand-Alone Interbody Fusion System | 2020 | 25 |
| K190885 | Elevation Spine Saber-C System | 2019 | 25 |
| K201073 | Seaspine WaveForm C Interbody System | 2020 | 17 |
| K191477 | AEON-C Stand Alone System | 2019 | 10 |
| K211417 | F3D-C2 Cervical Stand-Alone System | 2022 | 3 |
| K202065 | DOLOMITE Anterior Cervical Stabilization System | 2020 | 3 |
| K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) | 2025 | 1 |
| K223837 | SPIRA®-C Integrated Fixation System | 2023 | 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 33 years and passes through 13 companies; a new generation was cleared every 1.2 years on median.
- 25 of the 213 ancestors have a recall of any class.
- Of its descendants, K180909 (Globus Medical, Inc., 2018) has gone furthest, with 37 descendants of its own.
- 2 other devices also cite its predicate K152022.
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. 2017, 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?
All COALITION® Spacers 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. Hyperlordotic…
Read the full statement (367 words)
All COALITION® Spacers 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. Hyperlordotic implants (≥20°) must be used with supplemental fixation in addition to the two bone screws or anchors. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical and/or corticocancellous bone. All COALITION® TPS coated spacers are indicated for the same use as non-coated PEEK versions.
The COALITION® Spacer and COALITION AGX® Plate and Spacer assembly are stand-alone integrated interbody fusion devices intended for use at one or two levels of the cervical spine (C2-T1) and used with two titanium alloy screws which accompany the implant.
The COALITION MIS® Spacer is an integrated interbody fusion device intended to be used with two titanium alloy screws and/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.
COALITION AGX® Spacer is an interbody fusion device intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation, for one or two levels of the cervical spine (C2-T1). 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 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/K173115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173115
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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