510(k) · Cleared
ClearedCoroent Thoracolumbar Implants
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 Jun 26, 2014 as substantially equivalent to K071795 (Nuvasive, Inc., 2007) and 2 other predicates after a 104-day review. Its family tree reaches back 4 generations to 1996. 483 later devices descend from it.
- Decided
- Jun 26, 2014
- Review
- 104 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to P950002 (1996). 10 ancestors in all. 483 later devices descend from it, 2 citing it directly.
- Root · 4 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 3 generations backK092901 Epicage Interbody Fusion DeviceR Tree Innovations · 2010
- 2 generations backK130548 Epicage Interbody Fusion DeviceAlphatec Spine, Inc. · 2013
- 1 generation backK132601 Coroent Sterile Implants SystemNu Vasive, Incorporated · 2013
- This deviceK140659 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 · cites it directly · 402 of its ownK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
- Descendant · 2 generations on · 400 of its ownK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
- Descendant · 3 generations on · 396 of its ownK160051 NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016
Showing 5 of 483 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 483 · See all- 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 · cites it directly402descendants
- K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016 · 2 generations on400descendants
- K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016 · 3 generations on396descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −3 | K092901 | Epicage Interbody Fusion Device | R Tree Innovations | 2010 | — |
| −2 | K130548 | Epicage Interbody Fusion Device | Alphatec Spine, Inc. | 2013 | — |
| −1 | K132601 | Coroent Sterile Implants System | Nu Vasive, Incorporated | 2013 | — |
| 0 (this device) | 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 | — |
| +1 | K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | 2015 | — |
| +2 | K153419 | NuVasive CoRoent Thoracolumbar System | Nu Vasive, Incorporated | 2016 | — |
| +3 | K160051 | NuVasive® Interfixated Interbody System | Nu Vasive, Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 8 | 0 |
| 2017 | 18 | 0 |
| 2018 | 23 | 0 |
| 2019 | 31 | 0 |
| 2020 | 46 | 0 |
| 2021 | 41 | 0 |
| 2022 | 56 | 0 |
| 2023 | 67 | 0 |
| 2024 | 75 | 0 |
| 2025 | 64 | 0 |
| 2026 | 50 | 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? (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…C. Predicate Devices The subject NuVasive CoRoent Thoracolumbar Implants are substantially equivalent to the predicate devices, NuVasive CoRoent System (K07 1795), NuVasive CoRoent Titanium System (K 120918) and NuVasive CoRoent Sterile Implants System (Kl32601). D. Device Descrip… | 2007 |
| * | K120918 | Nuvasive Coroent Titanium SystemSummary page 1…e CoRoent Thoracolumbar Implants are substantially equivalent to the predicate devices, NuVasive CoRoent System (K07 1795), NuVasive CoRoent Titanium System (K 120918) and NuVasive CoRoent Sterile Implants System (Kl32601). D. Device Description The CoRoent Thoracolumbar Implants are m… | 2012 |
| * | K132601 | Coroent Sterile Implants System | 2013 |
What descends from it? (483)
See all 4832 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 18 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K141896 (Nu Vasive, Incorporated, 2014) has gone furthest, with 480 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. 2014, 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 Implants are devices indicated for the following: Intervertebral Body Fusion The NuVasive CoRoent Thoracolumbar Implants are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the thoracolumbar spine. The devices are to be…
Read the full statement (299 words)
The NuVasive® CoRoent® Thoracolumbar Implants are devices indicated for the following:
Intervertebral Body Fusion
The NuVasive CoRoent Thoracolumbar Implants are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation system 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.
Thoracic Spine:
The CoRoent Thoracolumbar Implants are intended for use for thoracic interbody fusions at one or two contiguous levels in the thoracic spine from T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of asymptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).
Lumbar Spine:
The CoRoent Thoracolumbar Implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L1-L2 to L5-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.
Partial Vertebral Body Replacement
The NuVasive CoRoent Thoracolumbar Implants may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 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 implants are intended to be used with supplemental internal spinal fixation systems (e.g. pedicle screw system) 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/K140659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140659: Coroent Thoracolumbar Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140659
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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