510(k) · Cleared
ClearedNuVasive CoRoent Thoracolumbar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 13, 2016 as substantially equivalent to K151472 (Nu Vasive, Incorporated, 2015) and 1 other predicate after a 140-day review. Its family tree reaches back 16 generations to 1984. 400 later devices descend from it.
- Decided
- Apr 13, 2016
- Review
- 140 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K841189 (1984). 164 ancestors in all. 400 later devices descend from it, 6 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 2 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 1 generation backK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
- This deviceK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
- Descendant · cites it directly · 396 of its ownK160051 NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016
- Descendant · cites it directly · 381 of its ownK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- Descendant · cites it directly · 304 of its ownK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 276 of its ownK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 251 of its ownK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
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 backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 2 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 1 generation backK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
- This deviceK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
Showing 5 of 400 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 400 · See all- K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016 · cites it directly396descendants
- K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · cites it directly381descendants
- K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017 · cites it directly304descendants
- K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 2 generations on276descendants
- K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017 · 2 generations on251descendants
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 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| −2 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| −1 | K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | 2015 | — |
| 0 (this device) | K153419 | NuVasive CoRoent Thoracolumbar System | Nu Vasive, Incorporated | 2016 | — |
| +1 | K160051 | NuVasive® Interfixated Interbody System | Nu Vasive, Incorporated | 2016 | — |
| +1 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| +1 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K163230 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K171633 | NuVasive TLX 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 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 17 | 0 |
| 2005 | 10 | 0 |
| 2006 | 5 | 0 |
| 2007 | 11 | 0 |
| 2008 | 23 | 0 |
| 2009 | 11 | 0 |
| 2010 | 8 | 0 |
| 2011 | 9 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 3 | 0 |
| 2017 | 13 | 0 |
| 2018 | 16 | 0 |
| 2019 | 20 | 0 |
| 2020 | 33 | 0 |
| 2021 | 36 | 0 |
| 2022 | 49 | 0 |
| 2023 | 54 | 0 |
| 2024 | 73 | 0 |
| 2025 | 57 | 0 |
| 2026 | 46 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | K151472 | NuVasive CoRoent Lumbar SystemSummary page 4…MAX, PHM C. Predicate Devices The subject NuVasive CoRoent Thoracolumbar System is substantially equivalent to primary predicate CoRoent Lumbar System (K151472), and additional predicate CoRoent Thoracolumbar Implants (K150994). D. Device Description The subject NuVasive CoR… | 2015 |
| * | K150994 | NuVasive CoRoent Thoracolumbar ImplantsSummary page 4…Thoracolumbar System is substantially equivalent to primary predicate CoRoent Lumbar System (K151472), and additional predicate CoRoent Thoracolumbar Implants (K150994). D. Device Description The subject NuVasive CoRoent Thoracolumbar System are interbodies manufactured from PEEK-Op… | 2015 |
What descends from it? (400)
See all 4006 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 |
| K161230 | NuVasive Lumbar Interbody Implants | 2016 | 381 |
| K170962 | NuVasive® CoRoent® Thoracolumbar System | 2017 | 304 |
| K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL… | 2020 | 156 |
| K203201 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL… | 2021 | 94 |
| K171434 | ROCCIA® MultiLIF | 2017 | 4 |
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 32 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
- 19 of the 164 ancestors have a recall of any class.
- Of its descendants, K160051 (Nu Vasive, Incorporated, 2016) has gone furthest, with 396 descendants of its own.
- 4 other devices also cite its predicate K151472.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The NuVasive CoRoent Thoracolumbar 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 and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The CoRoent Thoracolumbar System (XL…
Read the full statement (207 words)
The NuVasive CoRoent Thoracolumbar 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 and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The CoRoent Thoracolumbar System (XL platform) implants are intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The CoRoent Thoracolumbar System (XL and L platforms) implants are intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, 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 CoRoent Thoracolumbar System (XL and L platforms) implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153419: NuVasive CoRoent Thoracolumbar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153419
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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