510(k) · Cleared
ClearedVertera Spine Cohere Cervical Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Nov 21, 2017 as substantially equivalent to K143685 (Vertera, Inc., 2015) and 1 other predicate after a 54-day review. Its family tree reaches back 15 generations to 1984. 22 later devices descend from it.
- Decided
- Nov 21, 2017
- Review
- 54 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K841189 (1984). 56 ancestors in all. 22 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
- 2 generations backK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
- 1 generation backK163491 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2017
- This deviceK173030 Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated · 2017
- Descendant · cites it directly · 9 of its ownK231735 NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small…Nu Vasive, Incorporated · 2023
- Descendant · cites it directly · 6 of its ownK222004 INTEGRATE -C Interbody Fusion SystemHappe Spine · 2023
- Descendant · 2 generations on · 4 of its ownK232150 ZSFab Cervical Interbody SystemZsfab, Inc. · 2023
- Descendant · cites it directly · 4 of its ownK220875 HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc. · 2022
- Descendant · 2 generations on · 3 of its ownK241375 IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody…Alphatec Spine · 2025
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 9 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 8 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 7 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 6 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 5 generations backK123206 Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013
- 4 generations backK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014
- 3 generations backK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
- 2 generations backK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
- 1 generation backK163491 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2017
- This deviceK173030 Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated · 2017
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated · 2023 · cites it directly9descendants
- K222004INTEGRATE -C Interbody Fusion SystemHappe Spine · 2023 · cites it directly6descendants
- K232150ZSFab Cervical Interbody SystemZsfab, Inc. · 2023 · 2 generations on4descendants
- K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc. · 2022 · cites it directly4descendants
- K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine · 2025 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −9 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −8 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −7 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −6 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −5 | K123206 | Maxim Surgical X-Treme Interbody Fusion System | Maxim Surgical | 2013 | — |
| −4 | K140003 | Coroent Small Interbody System | Nuvasive, Inc. | 2014 | — |
| −3 | K140921 | Coroent Small Interbody System | Nu Vasive, Incorporated | 2014 | — |
| −2 | K150362 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2015 | — |
| −1 | K163491 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2017 | — |
| 0 (this device) | K173030 | Vertera Spine Cohere Cervical Interbody Fusion Device | Nu Vasive, Incorporated | 2017 | — |
| +1 | K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured… | Nu Vasive, Incorporated | 2023 | — |
| +1 | K222004 | INTEGRATE -C Interbody Fusion System | Happe Spine | 2023 | — |
| +2 | K232150 | ZSFab Cervical Interbody System | Zsfab, Inc. | 2023 | — |
| +1 | K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF System | Innovasis, Inc. | 2022 | — |
| +2 | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System… | Alphatec Spine | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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? (2)
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 |
|---|---|---|---|
| * | K143685 | Hedgehog Cervical Interbody Fusion DeviceSummary page 4…Spine™ Cohere® Cervical Interbody Fusion Device is substantially equivalent to the primary predicate device, Vertera Hedgehog Cervical Interbody Fusion Device (K143685), and additional predicate NuVasive CoRoent Small Interbody System (K163491). D. Device Description The subject Vert… | 2015 |
| * | K163491 | NuVasive CoRoent Small Interbody SystemSummary page 4…to the primary predicate device, Vertera Hedgehog Cervical Interbody Fusion Device (K143685), and additional predicate NuVasive CoRoent Small Interbody System (K163491). D. Device Description The subject Vertera Spine Cohere Cervical Interbody Fusion Device, previously cleared as pre… | 2017 |
What descends from it? (22)
See all 223 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 companies; a new generation was cleared every 1.1 years on median.
- 7 of the 56 ancestors have a recall of any class.
- Of its descendants, K231735 (Nu Vasive, Incorporated, 2023) has gone furthest, with 9 descendants of its own.
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?
The Vertera Spine™ Cohere® Cervical Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Vertera Spine Cohere Cervical Interbody Fusion Device is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at…
Read the full statement (104 words)
The Vertera Spine™ Cohere® Cervical Interbody Fusion Device is indicated for intervertebral body fusion of the spine in
skeletally mature patients. The Vertera Spine Cohere Cervical Interbody Fusion Device is intended for use for anterior
cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by
imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous
levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with
autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate
fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173030: Vertera Spine Cohere Cervical Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173030
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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