510(k) · Cleared
ClearedNuvasive Coroent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Oct 2, 2008 after a 115-day review. The FDA summary names no predicate by number. 1 of the 830 devices in its family, counting itself, has a Class I recall. 829 later devices descend from it.
- Decided
- Oct 2, 2008
- Review
- 115 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 0
829 later devices descend from it, 18 citing it directly. 1 of the 830 devices in this family, counting this one, has a Class I recall.
- This deviceK081611 Nuvasive Coroent SystemNuvasive, Inc. · 2008
- Descendant · cites it directly · 641 of its ownK101051 Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine · 2010
- Descendant · 2 generations on · 636 of its ownK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- Descendant · cites it directly · 595 of its ownK131082 Interform Interbody Cage SystemNext Orthosurgical · 2013
- Descendant · 2 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 3 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
Showing 5 of 829 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 829 · See all- K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine · 2010 · cites it directly641descendants
- K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation · 2015 · 2 generations on636descendants
- K131082Interform Interbody Cage SystemNext Orthosurgical · 2013 · cites it directly595descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 2 generations on588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 3 generations on479descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081611 | Nuvasive Coroent System | Nuvasive, Inc. | 2008 | — |
| +1 | K101051 | Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXX | Stryker Spine | 2010 | — |
| +2 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| +1 | K131082 | Interform Interbody Cage System | Next Orthosurgical | 2013 | — |
| +2 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +3 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 7 | 0 |
| 2015 | 20 | 0 |
| 2016 | 30 | 0 |
| 2017 | 59 | 0 |
| 2018 | 66 | 0 |
| 2019 | 76 | 0 |
| 2020 | 82 | 0 |
| 2021 | 66 | 1 |
| 2022 | 76 | 0 |
| 2023 | 94 | 0 |
| 2024 | 93 | 0 |
| 2025 | 80 | 0 |
| 2026 | 72 | 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (829)
See all 82918 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101051 | Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXX | 2010 | 641 |
| K131082 | Interform Interbody Cage System | 2013 | 595 |
| K140003 | Coroent Small Interbody System | 2014 | 453 |
| K142050 | Nuvasive Coroent Small Contoured Interbody System | 2014 | 449 |
| K140921 | Coroent Small Interbody System | 2014 | 444 |
| K150362 | NuVasive CoRoent Small Interbody System | 2015 | 441 |
| K133557 | Juliet LL Lateral Lumbar Cage | 2014 | 147 |
| K162138 | NuVasive CoRoent Small Ti-C System | 2016 | 135 |
| K172676 | NuVasive® Modulus-C Interbody System | 2017 | 125 |
| K161442 | NuVasive® CoRoent® Small Interlock™ System | 2016 | 94 |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K101051 (Stryker Spine, 2010) has gone furthest, with 641 descendants of its own.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
Intervertebral Body Fusion The NuVasive CoRoent 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 L and XL platforms are 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 (DDD) with up to Grade I spondylolisthesis. DDD is…
Read the full statement (304 words)
Intervertebral Body Fusion
The NuVasive CoRoent 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 L and XL platforms are 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 (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 that are cleared by the FDA for use in the lumbar spine.
The CoRoent S platforms are intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from levels C2-C3 to C7- T1. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment. The System is intended to be used with supplemental fixation and autogenous bone graft only to facilitate the fusion.
Partial Vertebral Body Replacement
The NuVasive CoRoent System 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 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/K081611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081611: Nuvasive Coroent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081611
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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