510(k) · Cleared
ClearedNuVasive X-CORE Mini Cervical Expandable VBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · PLR Spinal Vertebral Body Replacement Device - Cervical
Cleared on Sep 25, 2015 as substantially equivalent to K142205 (Nuvasive, Inc., 2015) and 1 other predicate after a 99-day review. Its family tree reaches back 5 generations to 1984. 68 later devices descend from it.
- Decided
- Sep 25, 2015
- Review
- 99 days
- Class
- Class II
- Product code
- PLR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K841189 (1984). 11 ancestors in all. 68 later devices descend from it, 9 citing it directly.
- Root · 5 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 4 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 3 generations backK003836 Synthes Synex Spacer SystemSynthes · 2001 · Recalled
- 2 generations backK061891 Synex IISynthes Spine Co.Lp · 2006
- 1 generation backK142205 NuVasive X-CORE (R) Expandable VBR SystemNuvasive, Inc. · 2015
- This deviceK151651 NuVasive X-CORE Mini Cervical Expandable VBR SystemNu Vasive, Incorporated · 2015
- Descendant · cites it directly · 57 of its ownK152568 C-VBRCardinal Spine, LLC · 2016
- Descendant · cites it directly · 55 of its ownK162315 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017
- Descendant · cites it directly · 46 of its ownK172032 Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. · 2017
- Descendant · cites it directly · 28 of its ownK181328 T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018
- Descendant · 2 generations on · 27 of its ownK183510 T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2019
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 68 · See all- K152568C-VBRCardinal Spine, LLC · 2016 · cites it directly57descendants
- K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017 · cites it directly55descendants
- K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. · 2017 · cites it directly46descendants
- K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018 · cites it directly28descendants
- K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2019 · 2 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −4 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −3 | K003836 | Synthes Synex Spacer System | Synthes | 2001 | 11 |
| −2 | K061891 | Synex II | Synthes Spine Co.Lp | 2006 | — |
| −1 | K142205 | NuVasive X-CORE (R) Expandable VBR System | Nuvasive, Inc. | 2015 | — |
| 0 (this device) | K151651 | NuVasive X-CORE Mini Cervical Expandable VBR System | Nu Vasive, Incorporated | 2015 | — |
| +1 | K152568 | C-VBR | Cardinal Spine, LLC | 2016 | — |
| +1 | K162315 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2017 | — |
| +1 | K172032 | Modulift Vertebral Body Replacement (VBR) System | Aesculap Implants Systems, Inc. | 2017 | — |
| +1 | K181328 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| +2 | K183510 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 10 | 0 |
| 2020 | 6 | 0 |
| 2022 | 4 | 0 |
| 2023 | 8 | 0 |
| 2024 | 10 | 0 |
| 2025 | 7 | 0 |
| 2026 | 14 | 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 PLR? 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 PLR device
- #1 K232481 RIGEL™ 3DR Anterior Cervical Corpectomy Systemscore 13.1 · 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 |
|---|---|---|---|
| * | K142205 | NuVasive X-CORE (R) Expandable VBR SystemSummary page 4…ject NuVasive® X-Core® Mini Cervical Expandable VBR System is substantially equivalent to the primary predicate device NuVasive® X-Core® Expandable VBR System (K142205) and the additional predicate device, NuVasive® CoRoent® System (K081611). D. Device Description The X-Core® Mini Cervica… | 2015 |
| * | K081611 | Nuvasive Coroent SystemSummary page 4…ly equivalent to the primary predicate device NuVasive® X-Core® Expandable VBR System (K142205) and the additional predicate device, NuVasive® CoRoent® System (K081611). D. Device Description The X-Core® Mini Cervical Expandable VBR System is manufactured from Ti-6Al-4V ELI conformin… | 2008 |
What descends from it? (68)
See all 689 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152568 | C-VBR | 2016 | 57 |
| K162315 | FORTIFY Corpectomy Spacers | 2017 | 55 |
| K172032 | Modulift Vertebral Body Replacement (VBR) System | 2017 | 46 |
| K181328 | T2 STRATOSPHERE™ Expandable Corpectomy System | 2018 | 28 |
| K180550 | NuVasive Monolith Cervical Corpectomy System | 2018 | 11 |
| K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | 2018 | 9 |
| K183071 | VLIFT-s Vertebral Body Replacement System | 2019 | 4 |
| K193506 | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System | 2020 | 1 |
| K212126 | MediExpand Cervical Expandable VBR System | 2022 | 0 |
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 31 years and passes through 6 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K152568 (Cardinal Spine, LLC, 2016) has gone furthest, with 57 descendants of its own.
- 7 other devices also cite its predicate K142205.
How does its category compare?
All PLR devicesPLR Spinal Vertebral Body Replacement Device - Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PLR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLR
69in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLR
No recall names PLR since 2007.
Adverse event reports per year · PLR
1in 2025
MAUDE reports naming product code PLR, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 259 | 0 | 1 |
| 2019 | 5 | 69 | 0 | 1 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The NuVasive® X-Core® Mini Cervical Expandable VBR System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The NuVasive® X-Core®…
Read the full statement (173 words)
The NuVasive® X-Core® Mini Cervical Expandable VBR System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The NuVasive® X-Core® Mini Cervical Expandable VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The NuVasive® X-Core® Mini Cervical Expandable VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151651: NuVasive X-CORE Mini Cervical Expandable VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151651
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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