510(k) · Cleared
ClearedCoroent Single Tab System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Sep 20, 2013 as substantially equivalent to K071795 (Nuvasive, Inc., 2007) and 2 other predicates after a 100-day review. Its family tree reaches back 11 generations to 1984. 1 of the 496 devices in its family, counting itself, has a Class I recall. 466 later devices descend from it.
- Decided
- Sep 20, 2013
- Review
- 100 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K841189 (1984). 29 ancestors in all. 466 later devices descend from it, 3 citing it directly. 1 of the 496 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 1 generation backK103382 Intercontinental Plate-SpacerGlobus Medical, Inc. · 2011
- This deviceK131723 Coroent Single Tab SystemNuvasive, Inc. · 2013
- Descendant · cites it directly · 465 of its ownK140479 Coroent XL-F SystemNu Vasive, Incorporated · 2014
- Descendant · cites it directly · 396 of its ownK160051 NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016
- Descendant · cites it directly · 390 of its ownK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- Descendant · 2 generations on · 381 of its ownK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- Descendant · 3 generations on · 304 of its ownK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 7 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 6 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 5 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 1 generation backK103382 Intercontinental Plate-SpacerGlobus Medical, Inc. · 2011
- This deviceK131723 Coroent Single Tab SystemNuvasive, Inc. · 2013
Showing 5 of 466 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 466 · See all- K140479Coroent XL-F SystemNu Vasive, Incorporated · 2014 · cites it directly465descendants
- K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016 · cites it directly396descendants
- K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · cites it directly390descendants
- K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · 2 generations on381descendants
- K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017 · 3 generations on304descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −7 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −6 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −5 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −3 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −2 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −1 | K103382 | Intercontinental Plate-Spacer | Globus Medical, Inc. | 2011 | — |
| 0 (this device) | K131723 | Coroent Single Tab System | Nuvasive, Inc. | 2013 | — |
| +1 | K140479 | Coroent XL-F System | Nu Vasive, Incorporated | 2014 | — |
| +1 | K160051 | NuVasive® Interfixated Interbody System | Nu Vasive, Incorporated | 2016 | — |
| +1 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| +2 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| +3 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 10 | 0 |
| 2017 | 16 | 0 |
| 2018 | 19 | 0 |
| 2019 | 24 | 0 |
| 2020 | 42 | 0 |
| 2021 | 43 | 1 |
| 2022 | 52 | 0 |
| 2023 | 59 | 0 |
| 2024 | 81 | 0 |
| 2025 | 64 | 0 |
| 2026 | 54 | 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.
1 device in this family has a Class I recall. 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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 |
|---|---|---|---|
| * | K071795 | Nuvasive Coroent SystemSummary page 1…OVD. MAX C. Predicate Devices The subject CoRoent Single TabSytem is substantially equivalent to the following predicate devices: Nul/asive CoRoent System (K071 795), Nul/asive Sage Lateral Plate Systemi (K 121815), and Globus InterContinentalPlate-Spacer (K 103382). D. Device Descript… | 2007 |
| * | K121815 | Nuvasive Sage Lateral Plate SystemSummary page 1…oent Single TabSytem is substantially equivalent to the following predicate devices: Nul/asive CoRoent System (K071 795), Nul/asive Sage Lateral Plate Systemi (K 121815), and Globus InterContinentalPlate-Spacer (K 103382). D. Device Description The NuVasive CoRoent Single Tab System is man… | 2012 |
| * | K103382 | Intercontinental Plate-SpacerSummary page 1…the following predicate devices: Nul/asive CoRoent System (K071 795), Nul/asive Sage Lateral Plate Systemi (K 121815), and Globus InterContinentalPlate-Spacer (K 103382). D. Device Description The NuVasive CoRoent Single Tab System is manufactured from PEEK-Optima®& LT-lI conforming t… | 2011 |
What descends from it? (466)
See all 4663 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- None of the 29 ancestors has a recall.
- Of its descendants, K140479 (Nu Vasive, Incorporated, 2014) has gone furthest, with 465 descendants of its own.
- 41 other devices also cite its predicate K071795.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The NuVasive CoRoent Single Tab System is indicated far intervertebral body fusion of the spine in skeletally mature patients. The System is designed far use with autogenous bone graft to facilitate fusion. The CoRoent Single Tab System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to L5, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain…
Read the full statement (145 words)
The NuVasive CoRoent Single Tab System is indicated far intervertebral body fusion of the spine in skeletally mature patients. The System is designed far use with autogenous bone graft to facilitate fusion.
The CoRoent Single Tab System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to L5, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The devices are to be used in patients who have had at least six months of non-operative treatment. The system is intended to be used with supplemental internal spinal fixation systems (e.g., pedlicle or facet screws) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screw.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131723: Coroent Single Tab System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131723
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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