510(k) · Cleared
ClearedNuvasive Coroent Titanium System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 28, 2012 as substantially equivalent to K071795 (Nuvasive, Inc., 2007) after a 93-day review. Its family tree reaches back 2 generations to 2007. 1 of the 645 devices in its family, counting itself, has a Class I recall. 642 later devices descend from it.
- Decided
- Jun 28, 2012
- Review
- 93 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K071922 (2007). 642 later devices descend from it, 12 citing it directly. 1 of the 645 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK071922 Interplate Interbody Fusion Device, Models C, CGC, L and LGCRsb Spine, LLC · 2007
- 1 generation backK071795 Nuvasive Coroent SystemNuvasive, Inc. · 2007
- This deviceK120918 Nuvasive Coroent Titanium SystemNuvasive, Inc. · 2012
- Descendant · cites it directly · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · cites it directly · 483 of its ownK140659 Coroent Thoracolumbar ImplantsNu Vasive, Incorporated · 2014
- Descendant · cites it directly · 480 of its ownK141896 Coroent SystemNu Vasive, Incorporated · 2014
- Descendant · 2 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- Descendant · 2 generations on · 402 of its ownK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
Showing 5 of 642 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 642 · See all- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · cites it directly588descendants
- K140659Coroent Thoracolumbar ImplantsNu Vasive, Incorporated · 2014 · cites it directly483descendants
- K141896Coroent SystemNu Vasive, Incorporated · 2014 · cites it directly480descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 2 generations on479descendants
- K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015 · 2 generations on402descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071922 | Interplate Interbody Fusion Device, Models C, CGC, L and LGC | Rsb Spine, LLC | 2007 | — |
| −1 | K071795 | Nuvasive Coroent System | Nuvasive, Inc. | 2007 | — |
| 0 (this device) | K120918 | Nuvasive Coroent Titanium System | Nuvasive, Inc. | 2012 | — |
| +1 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +1 | K140659 | Coroent Thoracolumbar Implants | Nu Vasive, Incorporated | 2014 | — |
| +1 | K141896 | Coroent System | Nu Vasive, Incorporated | 2014 | — |
| +2 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
| +2 | K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 12 | 0 |
| 2016 | 19 | 0 |
| 2017 | 33 | 0 |
| 2018 | 38 | 0 |
| 2019 | 49 | 0 |
| 2020 | 66 | 0 |
| 2021 | 55 | 1 |
| 2022 | 63 | 0 |
| 2023 | 81 | 0 |
| 2024 | 86 | 0 |
| 2025 | 73 | 0 |
| 2026 | 60 | 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 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? (1)
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…QP C. Predicate Devices The subject NuVasive CoRoent Titanium System is substantially equivalent to the following predicate device: NuVasive CoRoent System (K071795) D. Device Description The NuVasive CoRoent Titanium System is a lumbar interbody system manufactured from titanium… | 2007 |
What descends from it? (642)
See all 64212 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141665 | NuVasive CoRoent System | 2015 | 588 |
| K140659 | Coroent Thoracolumbar Implants | 2014 | 483 |
| K141896 | Coroent System | 2014 | 480 |
| K170962 | NuVasive® CoRoent® Thoracolumbar System | 2017 | 304 |
| K140770 | MLX - Medial Lateral Expandable Lumbar Interbody System | 2014 | 269 |
| K143595 | NuVasive (R) CCX-L Interbody System | 2015 | 253 |
| K153627 | NuVasive® TLX Interbody System | 2016 | 252 |
| K153105 | MLX™ - Medial Lateral Expandable Lumbar Interbody System | 2016 | 234 |
| K151214 | ALIF Interfixated System | 2015 | 220 |
| K141135 | Juliet LL | 2014 | 146 |
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 5 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K141665 (Nuvasive, Inc., 2015) has gone furthest, with 588 descendants of its own.
- 41 other devices also cite its predicate K071795.
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. 2012, 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?
Intervertebral Body Fusion The NuVasive CoRoent Titanium 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 Titanium System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (ODD) with up to Grade I spondylolisthesis. ODD is…
Read the full statement (235 words)
Intervertebral Body Fusion
The NuVasive CoRoent Titanium 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 Titanium System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (ODD) with up to Grade I spondylolisthesis. ODD 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 that are cleared by the FDA for use in the lumbar spine.
Partial Vertebral Body Replacement
The NuVasive CoRoent Titanium System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (Ti to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120918 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120918: Nuvasive Coroent Titanium System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120918
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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