510(k) Report

510(k) · Cleared

Cleared

NuVasive X-CORE (R) Expandable VBR System

K142205510(k) TraditionalCleared Feb 20, 2015193-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nuvasive, Inc. · MQP Spinal Vertebral Body Replacement Device

Cleared on Feb 20, 2015 as substantially equivalent to K090176 (Nuvasive, Inc., 2009) and 4 other predicates after a 193-day review. Its family tree reaches back 4 generations to 1984. 74 later devices descend from it.

Decided
Feb 20, 2015
Review
193 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K841189 (1984). 9 ancestors in all. 74 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2003: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor2015: 3 descendants cleared2019: 11 descendants cleared2020: 6 descendants cleared2017: 3 descendants cleared2026: 15 descendants cleared2018: 6 descendants cleared2016: 1 descendant cleared2022: 4 descendants cleared2023: 8 descendants cleared2024: 10 descendants cleared2025: 7 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003836 · Synthes Synex Spacer System · Synthes · 2001 · recalledK061891 · Synex II · Synthes Spine Co.Lp · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors 1 generation forward: 8 descendants2 generations forward: 10 descendants3 generations forward: 17 descendants4 generations forward: 13 descendants5 generations forward: 4 descendants6 generations forward: 3 descendants7 generations forward: 11 descendants8 generations forward: 6 descendants9 generations forward: 1 descendant10 generations forward: 1 descendant K061891 · Synex II · Synthes Spine Co.Lp · 2006K003836 · Synthes Synex Spacer System · Synthes · 2001 · recalledK990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 19840+5+10
  1. Root · 4 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 3 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 2 generations backK003836 Synthes Synex Spacer SystemSynthes · 2001 · Recalled
  4. 1 generation backK061891 Synex IISynthes Spine Co.Lp · 2006
  5. This deviceK142205 NuVasive X-CORE (R) Expandable VBR SystemNuvasive, Inc. · 2015
  6. Descendant · cites it directly · 68 of its ownK151651 NuVasive X-CORE Mini Cervical Expandable VBR SystemNu Vasive, Incorporated · 2015
  7. Descendant · 2 generations on · 57 of its ownK152568 C-VBRCardinal Spine, LLC · 2016
  8. Descendant · 2 generations on · 55 of its ownK162315 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017
  9. Descendant · 2 generations on · 46 of its ownK172032 Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. · 2017
  10. Descendant · 2 generations on · 28 of its ownK181328 T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018

Showing 5 of 74 descendants. See all descendants

Descendants cleared per year

2015: 32016: 12017: 32018: 62019: 112020: 62022: 42023: 82024: 102025: 72026: 15
2015high 15 (2026) · low 0 (2021)2026

Most influential descendants

Showing 5 of 74 · See all
  • K151651NuVasive X-CORE Mini Cervical Expandable VBR SystemNu Vasive, Incorporated · 2015 · cites it directly68descendants
  • K152568C-VBRCardinal Spine, LLC · 2016 · 2 generations on57descendants
  • K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017 · 2 generations on55descendants
  • K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. · 2017 · 2 generations on46descendants
  • K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018 · 2 generations on28descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−3K990148Stackable Cage SystemDepuy Motech Acromed1999—
−2K003836Synthes Synex Spacer SystemSynthes200111
−1K061891Synex IISynthes Spine Co.Lp2006—
0 (this device)K142205NuVasive X-CORE (R) Expandable VBR SystemNuvasive, Inc.2015—
+1K151651NuVasive X-CORE Mini Cervical Expandable VBR SystemNu Vasive, Incorporated2015—
+2K152568C-VBRCardinal Spine, LLC2016—
+2K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.2017—
+2K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.2017—
+2K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200120
200310
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201530
201610
201730
201860
2019110
202060
202240
202380
2024100
202570
2026150
FIG. 1 — Lineage of K142205, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K090176Nuvasive Adjustable Vertebral Body Replacement System
Summary page 4
…cate Devices The subject X-Core® Expandable VBR System is substantially equivalent to the primary predicate device NuVasive Expandable Lumbar Interbody System (K090176) and additional predicate devices NuVasive Mesh (K032476), Osteotech VBR (K012254), DePuy Surgical Titanium Mesh System…
Nuvasive, Inc.20091
*K032476Nuvasive Mesh
Summary page 4
…substantially equivalent to the primary predicate device NuVasive Expandable Lumbar Interbody System (K090176) and additional predicate devices NuVasive Mesh (K032476), Osteotech VBR (K012254), DePuy Surgical Titanium Mesh System (K030349), and Synthes Spine Synex Spacer System (K003836 and…
Nuvasive, Inc.2003—
*K012254VBR
Summary page 4
…to the primary predicate device NuVasive Expandable Lumbar Interbody System (K090176) and additional predicate devices NuVasive Mesh (K032476), Osteotech VBR (K012254), DePuy Surgical Titanium Mesh System (K030349), and Synthes Spine Synex Spacer System (K003836 and K061891). D. Dev…
Osteotech, Inc.2001—
Kept off the family treeK030349FDA’s K030349 is Healthometer Professional Body Fat Monitor and Scale, Models BFM 940, BFM 945…
Our reading of the summary gave K030349, FDA’s number for Healthometer Professional Body Fat Monitor and Scale… (Bonso Electronics International, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “DePuy Surgical Titanium Mesh System”. Kept off the family tree.
Summary page 4
…dable Lumbar Interbody System (K090176) and additional predicate devices NuVasive Mesh (K032476), Osteotech VBR (K012254), DePuy Surgical Titanium Mesh System (K030349), and Synthes Spine Synex Spacer System (K003836 and K061891). D. Device Description The X-Core® Expandable VBR Syst…
Bonso Electronics International, Inc.2003—
*K003836Synthes Synex Spacer System
Summary page 4
…ional predicate devices NuVasive Mesh (K032476), Osteotech VBR (K012254), DePuy Surgical Titanium Mesh System (K030349), and Synthes Spine Synex Spacer System (K003836 and K061891). D. Device Description The X-Core® Expandable VBR System is manufactured from Ti-6Al-4V ELI conforming…
Synthes200111
*K061891Synex II
Summary page 4
…ate devices NuVasive Mesh (K032476), Osteotech VBR (K012254), DePuy Surgical Titanium Mesh System (K030349), and Synthes Spine Synex Spacer System (K003836 and K061891). D. Device Description The X-Core® Expandable VBR System is manufactured from Ti-6Al-4V ELI conforming to ASTM F136…
Synthes Spine Co.Lp2006—

What descends from it? (74)

See all 74

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151651NuVasive X-CORE Mini Cervical Expandable VBR SystemNu Vasive, Incorporated201568
K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated201513
K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated201513
K170271NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated201712
K191423Normandy VBR SystemZavation Medical Products, LLC20193
K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201
K261031Poseidon STSignus Medinzintechnik GmbH20260
K190349MediExpand TL Expandable VBR SystemCmf Medicon Surgical, Inc.20190

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 5 companies; a new generation was cleared every 8.5 years on median.
  • 2 of the 9 ancestors have a recall of any class.
  • Of its descendants, K151651 (Nu Vasive, Incorporated, 2015) has gone furthest, with 68 descendants of its own.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · MQP

4in 2024

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
2007high 15 (2020) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQP

168in 2025

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

What is it indicated for?

The NuVasive X-CORE® Expandable VBR System is a 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 NuVasive X-CORE Expandable VBR 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.

More from Nuvasive, Inc.

117 FDA decisions under this applicant name. See the company

  • P200022/S016Simplify® Cervical Artificial DiscNuvasive, Inc. · 2025
  • P200022/S017Simplify® Cervical Artificial DiscNuvasive, Inc. · 2025
  • P200022/S012Simplify DiscNuvasive, Inc. · 2025
  • P200022/S015Simplify Cervical Artificial DiscNuvasive, Inc. · 2025
  • P200022/S014Simplify Cervical Artificial DiscNuvasive, Inc. · 2024

Recent decisions in MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K142205 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142205: NuVasive X-CORE (R) 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/K142205

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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