510(k) · Cleared
Recalled · 2010Nuvasive Coroent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Feb 7, 2005 as substantially equivalent to K033517 (Spinal Concepts, Inc., 2004) and 3 other predicates after a 59-day review. Its family tree reaches back 4 generations to 2001. 712 later devices descend from it. It has been recalled once.
- Decided
- Feb 7, 2005
- Review
- 59 days
- Class
- Class II
- Product code
- MQP
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K010530 (2001). 12 ancestors in all, the oldest K001340 (2000). 712 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 3 generations backK020048 Modification to Geo StructureInterpore Cross Intl. · 2002
- 2 generations backK031914 Spinal Concepts, Inc. Cadence and FortitudeSpinal Concepts, Inc. · 2003
- 1 generation backK033517 Spinal Concepts Inc. Cadence and TraxisSpinal Concepts, Inc. · 2004 · Recalled
- This deviceK043405 Nuvasive Coroent SystemNuvasive, Inc. · 2005
- Descendant · cites it directly · 666 of its ownK051454 Aleutian Spacer SystemK2m, LLC · 2005
- Descendant · 2 generations on · 663 of its ownK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- Descendant · 2 generations on · 662 of its ownK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- Descendant · 3 generations on · 595 of its ownK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- Descendant · 2 generations on · 589 of its ownK110843 Aleutian Spacer SystemK2m, Inc. · 2011
Showing 5 of 712 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 712 · See all- K051454Aleutian Spacer SystemK2m, LLC · 2005 · cites it directly666descendants
- K063399Aleutian Spacer SystemK2m, Inc. · 2007 · 2 generations on663descendants
- K082698Aleutian Ibf SystemK2m, Inc. · 2009 · 2 generations on662descendants
- K101302Aleutian Ibf SystemK2m, Inc. · 2010 · 3 generations on595descendants
- K110843Aleutian Spacer SystemK2m, Inc. · 2011 · 2 generations on589descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −3 | K020048 | Modification to Geo Structure | Interpore Cross Intl. | 2002 | — |
| −2 | K031914 | Spinal Concepts, Inc. Cadence and Fortitude | Spinal Concepts, Inc. | 2003 | — |
| −1 | K033517 | Spinal Concepts Inc. Cadence and Traxis | Spinal Concepts, Inc. | 2004 | 1 |
| 0 (this device) | K043405 | Nuvasive Coroent System | Nuvasive, Inc. | 2005 | — |
| +1 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| +2 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| +2 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| +3 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| +2 | K110843 | Aleutian Spacer System | K2m, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 15 | 0 |
| 2015 | 18 | 0 |
| 2016 | 18 | 0 |
| 2017 | 40 | 0 |
| 2018 | 52 | 0 |
| 2019 | 47 | 0 |
| 2020 | 63 | 0 |
| 2021 | 62 | 0 |
| 2022 | 70 | 0 |
| 2023 | 86 | 0 |
| 2024 | 84 | 0 |
| 2025 | 66 | 0 |
| 2026 | 56 | 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 MQP? 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K033517 | Spinal Concepts Inc. Cadence and TraxisSummary page 2…ces As was established in this submission, the subject device is substantially equivalent to the following predicate devices: K033517 Spinal Concepts Cadence TM Spinal concepts, Inc. KO 11037 Vertebral Spacer Synthes… | 2004 |
| * | K011037 | Vertebral Spacer | 2002 |
| * | K032476 | Nuvasive MeshSummary page 2…K033517 Spinal Concepts Cadence TM Spinal concepts, Inc. KO 11037 Vertebral Spacer Synthes K032476 NuVasive Mesh NuVasive, Inc. K041939 Blackstone VBR System Blackstone Medical,… | 2003 |
| * | K041939 | Blackstone Peek Vertebral Body Replacement System Lordotic Lateral SpacersSummary page 2…. KO 11037 Vertebral Spacer Synthes K032476 NuVasive Mesh NuVasive, Inc. K041939 Blackstone VBR System Blackstone Medical, Inc. Engineering drawings, labeling, and mechanical testing have… | 2004 |
What descends from it? (712)
See all 7124 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 1, 2010 | Not classified | Z-2356-2010 | Process control | Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K051454 (K2m, LLC, 2005) has gone furthest, with 666 descendants of its own.
- 5 other devices also cite its predicate K033517.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The NuVasive CoRoent System is a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma 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/K043405 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043405: Nuvasive Coroent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043405
Report an extraction error
Are you the manufacturer?
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