510(k) · Cleared
ClearedCoroent XL-F System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Jul 28, 2014 as substantially equivalent to K131723 (Nuvasive, Inc., 2013) and 2 other predicates after a 152-day review. Its family tree reaches back 14 generations to 1984. 1 of the 554 devices in its family, counting itself, has a Class I recall. 465 later devices descend from it.
- Decided
- Jul 28, 2014
- Review
- 152 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K841189 (1984). 88 ancestors in all. 465 later devices descend from it, 8 citing it directly. 1 of the 554 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 2 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 1 generation backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- This deviceK140479 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
- Descendant · 3 generations on · 276 of its ownK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
Show all 14 generations
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 7 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 4 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 3 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 2 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 1 generation backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- This deviceK140479 Coroent XL-F SystemNu Vasive, Incorporated · 2014
Showing 5 of 465 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub3 generations on · 2021
Most influential descendants
Showing 5 of 465 · See all- 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
- K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 3 generations on276descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −13 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −12 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −11 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −8 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −7 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −4 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −3 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −2 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −1 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| 0 (this device) | 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 | — |
| +3 | K163230 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 9 | 0 |
| 2002 | 9 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 8 | 0 |
| 2008 | 10 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K131723 | Coroent Single Tab SystemSummary page 1…D C. Predicate Devices The subject NuVasive CoRoent XL-F System is substantially equivalent to the following predicate devices: NuJ~asive Single Tab System (K13 1723), NuVasive Brigade Hyperlordotic System (K123045), and Globus Medical InterContinentalPlate-Spacer(K103382). D. Device De… | 2013 |
| * | K123045 | Brigade Standalone SystemSummary page 1…oent XL-F System is substantially equivalent to the following predicate devices: NuJ~asive Single Tab System (K13 1723), NuVasive Brigade Hyperlordotic System (K123045), and Globus Medical InterContinentalPlate-Spacer(K103382). D. Device Description The NuVasive CoRoent XL-F System is man… | 2013 |
| * | K103382 | Intercontinental Plate-SpacerSummary page 1…ing predicate devices: NuJ~asive Single Tab System (K13 1723), NuVasive Brigade Hyperlordotic System (K123045), and Globus Medical InterContinentalPlate-Spacer(K103382). D. Device Description The NuVasive CoRoent XL-F System is manufactured from PEEK-Optima LT-l… | 2011 |
What descends from it? (465)
See all 4658 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160051 | NuVasive® Interfixated Interbody System | 2016 | 396 |
| K153782 | NuVasive® Lumbar Interbody Implants | 2016 | 390 |
| K172123 | NuVasive® Modulus XLIF Interbody System | 2017 | 227 |
| K192760 | NuVasive Modulus XLIF Interbody System | 2019 | 163 |
| K161379 | ELSA Spacers | 2016 | 155 |
| K161223 | TransContinental® M Spacers and InterContinental® Plate-Spacers | 2016 | 117 |
| K151312 | VerteLP Interbody Fusion Device | 2016 | 0 |
| K143228 | Ancora LLC Interbody Fusion Device | 2015 | 0 |
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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 12 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 88 ancestors have a recall of any class.
- Of its descendants, K160051 (Nu Vasive, Incorporated, 2016) has gone furthest, with 396 descendants of its own.
- 2 other devices also cite its predicate K131723.
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. 2014, 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 XL-F System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion. The CoRoent XL-F 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…
Read the full statement (145 words)
The NuVasive CoRoent XL-F System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion.
The CoRoent XL-F 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 lumbar 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., pedicle or facet screws) that are cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140479 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140479: Coroent XL-F System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140479
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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