510(k) · Cleared
ClearedCoroent Small Interbody System
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 Jul 28, 2014 as substantially equivalent to K081611 (Nuvasive, Inc., 2008) and 2 other predicates after a 109-day review. Its family tree reaches back 12 generations to 1984. 444 later devices descend from it.
- Decided
- Jul 28, 2014
- Review
- 109 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K841189 (1984). 43 ancestors in all. 444 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 2 generations backK123206 Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013
- 1 generation backK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014
- This deviceK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
- Descendant · cites it directly · 441 of its ownK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
- Descendant · 2 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
- Descendant · 2 generations on · 289 of its ownK163491 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · 3 generations on · 169 of its ownK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- Descendant · 3 generations on · 159 of its ownK172888 EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF…Eit Emerging Implant Technologies GmbH · 2017
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 6 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 5 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 4 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 3 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 2 generations backK123206 Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013
- 1 generation backK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014
- This deviceK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
Showing 5 of 444 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 444 · See all- K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015 · cites it directly441descendants
- K160125Cascadia Interbody SystemK2m · 2016 · 2 generations on315descendants
- K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2017 · 2 generations on289descendants
- K162264Cascadia Interbody SystemK2m, Inc. · 2016 · 3 generations on169descendants
- K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2017 · 3 generations on159descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −6 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −5 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −4 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −3 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −2 | K123206 | Maxim Surgical X-Treme Interbody Fusion System | Maxim Surgical | 2013 | — |
| −1 | K140003 | Coroent Small Interbody System | Nuvasive, Inc. | 2014 | — |
| 0 (this device) | K140921 | Coroent Small Interbody System | Nu Vasive, Incorporated | 2014 | — |
| +1 | K150362 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2015 | — |
| +2 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| +2 | K163491 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +3 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| +3 | K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT… | Eit Emerging Implant Technologies GmbH | 2017 | — |
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 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 16 | 0 |
| 2018 | 19 | 0 |
| 2019 | 30 | 0 |
| 2020 | 47 | 0 |
| 2021 | 38 | 0 |
| 2022 | 51 | 0 |
| 2023 | 66 | 0 |
| 2024 | 55 | 0 |
| 2025 | 61 | 0 |
| 2026 | 55 | 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? (3)
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 |
|---|---|---|---|
| * | K081611 | Nuvasive Coroent SystemSummary page 1…C. Predicate Devices The subject CoRoent Small Interbody System is substantially equivalent to the following predicate devices: NuVasive CoRoent System (K08 161 1), NuVasive CoRoent Small Interbody System (K 140003), and Medtronic Anatomic PEEK Cervical Fusion System (K1301 77).… | 2008 |
| * | K140003 | Coroent Small Interbody SystemSummary page 1…nterbody System is substantially equivalent to the following predicate devices: NuVasive CoRoent System (K08 161 1), NuVasive CoRoent Small Interbody System (K 140003), and Medtronic Anatomic PEEK Cervical Fusion System (K1301 77). DI. Device Description The Nul/asive CoRoent Smal… | 2014 |
| * | K130177 | Anatomic Peek Cervical Fusion SystemSummary page 1…edicate devices: NuVasive CoRoent System (K08 161 1), NuVasive CoRoent Small Interbody System (K 140003), and Medtronic Anatomic PEEK Cervical Fusion System (K1301 77). DI. Device Description The Nul/asive CoRoent Small Interbody System is manufactured from PEEK-Optima® LT-1I conf… | 2013 |
What descends from it? (444)
See all 4443 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 30 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 43 ancestors have a recall of any class.
- Of its descendants, K150362 (Nu Vasive, Incorporated, 2015) has gone furthest, with 441 descendants of its own.
- 17 other devices also cite its predicate K081611.
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. 2014, 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 NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at one level from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent SHL interbody device is required to be used with an anterior cervical plate as the…
Read the full statement (120 words)
The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at one level from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent SHL interbody device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140921: Coroent Small Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140921
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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