510(k) Report

510(k) · Cleared

Cleared

Lateral VBR System

K140563510(k) TraditionalCleared Aug 7, 2014155-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

Nu Vasive, Incorporated · MQP Spinal Vertebral Body Replacement Device

Cleared on Aug 7, 2014 as substantially equivalent to K032476 (Nuvasive, Inc., 2003) and 6 other predicates after a 155-day review. Its family tree reaches back 11 generations to 2001.

Decided
Aug 7, 2014
Review
155 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
7

Its longest line of descent runs back 11 generations to K003155 (2001). 62 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 2 other ancestors2009: 1 other ancestor2007: 2 other ancestors2006: 2 other ancestors2003: 12 other ancestors2005: 5 other ancestors2004: 11 other ancestors2001: 7 other ancestors2002: 5 other ancestors2000: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1984: 1 other ancestorK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×2: 2 generations cleared close together, K021791 (2002), K023570 (2002) K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004×2: 2 generations cleared close together, K042571 (2005), K050624 (2005) K062132 · Avs PL Peek Spacer System · Stryker Spine · 2006K070218 · Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR) · Vertiflex (Tm), Incorporated · 2007K102315 · Staxx XDL System · Spine Wave, Inc. · 201119801985199019952000200520102015
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 12 other ancestors3 generations back: 14 other ancestors4 generations back: 15 other ancestors5 generations back: 2 other ancestors6 generations back: 3 other ancestors K102315 · Staxx XDL System · Spine Wave, Inc. · 2011K070218 · Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR) · Vertiflex (Tm), Incorporated · 2007K062132 · Avs PL Peek Spacer System · Stryker Spine · 2006K050624 · Stryker Spine Avs PL Peek Spacer · Stryker Spine · 2005K042571 · Stryker Spine Avs TL Peek Spacer · Stryker Spine · 2005K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−10−50
  1. Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 7 generations between
  3. 3 generations backK062132 Avs PL Peek Spacer SystemStryker Spine · 2006
  4. 2 generations backK070218 Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated · 2007
  5. 1 generation backK102315 Staxx XDL SystemSpine Wave, Inc. · 2011
  6. This deviceK140563 Lateral VBR SystemNu Vasive, Incorporated · 2014
Show all 11 generations
  1. Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 10 generations backK012254 VBROsteotech, Inc. · 2001
  3. 9 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 8 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 7 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 6 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
  7. 5 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
  8. 4 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  9. 3 generations backK062132 Avs PL Peek Spacer SystemStryker Spine · 2006
  10. 2 generations backK070218 Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated · 2007
  11. 1 generation backK102315 Staxx XDL SystemSpine Wave, Inc. · 2011
  12. This deviceK140563 Lateral VBR SystemNu Vasive, Incorporated · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−10K012254VBROsteotech, Inc.2001—
−9K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−8K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−7K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−6K040731Stryker Spine Vertebral SpacerStryker Spine2004—
−5K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005—
−4K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005—
−3K062132Avs PL Peek Spacer SystemStryker Spine2006—
−2K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated2007—
−1K102315Staxx XDL SystemSpine Wave, Inc.2011—
0 (this device)K140563Lateral VBR SystemNu Vasive, Incorporated2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199810
199910
200010
200170
200250
2003120
2004110
200550
200620
200720
200910
201020
FIG. 1 — Lineage of K140563, 2001–2014Source: 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 510(k) statement (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? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K032476Nuvasive Mesh
Summary page 4
…C. Predicate Devices The subject Lateral VBR System is substantially equivalent to the following predicate devices: NuVasive Ti Mesh System (K032476), SpineWave StaXx XD System (K052670 and K090315), SpineWave StaXx XDL System (K102315), Osteotech, Inc. VBR™ (K012254)…
Nuvasive, Inc.2003—
*K052670Staxx XD System
Summary page 4
…The subject Lateral VBR System is substantially equivalent to the following predicate devices: NuVasive Ti Mesh System (K032476), SpineWave StaXx XD System (K052670 and K090315), SpineWave StaXx XDL System (K102315), Osteotech, Inc. VBR™ (K012254), NuVasive CoRoent System (…
Spine Wave, Inc.2006—
*K090315Staxx XD System
Summary page 4
…VBR System is substantially equivalent to the following predicate devices: NuVasive Ti Mesh System (K032476), SpineWave StaXx XD System (K052670 and K090315), SpineWave StaXx XDL System (K102315), Osteotech, Inc. VBR™ (K012254), NuVasive CoRoent System (K071795), and Aesculap…
Spine Wave, Inc.2009—
*K102315Staxx XDL System
Summary page 4
…t to the following predicate devices: NuVasive Ti Mesh System (K032476), SpineWave StaXx XD System (K052670 and K090315), SpineWave StaXx XDL System (K102315), Osteotech, Inc. VBR™ (K012254), NuVasive CoRoent System (K071795), and Aesculap Hydrolift VBR System (K083186). D…
Spine Wave, Inc.2011—
*K012254VBR
Summary page 4
…devices: NuVasive Ti Mesh System (K032476), SpineWave StaXx XD System (K052670 and K090315), SpineWave StaXx XDL System (K102315), Osteotech, Inc. VBR™ (K012254), NuVasive CoRoent System (K071795), and Aesculap Hydrolift VBR System (K083186). D. Device Description…
Osteotech, Inc.2001—
*K071795Nuvasive Coroent System
Summary page 4
…476), SpineWave StaXx XD System (K052670 and K090315), SpineWave StaXx XDL System (K102315), Osteotech, Inc. VBR™ (K012254), NuVasive CoRoent System (K071795), and Aesculap Hydrolift VBR System (K083186). D. Device Description The NuVasive Lateral VBR System is a verte…
Nuvasive, Inc.2007—
*K083186Aesculap Hydrolift VBR System
Summary page 4
…K090315), SpineWave StaXx XDL System (K102315), Osteotech, Inc. VBR™ (K012254), NuVasive CoRoent System (K071795), and Aesculap Hydrolift VBR System (K083186). D. Device Description The NuVasive Lateral VBR System is a vertebral body replacement device manufactured…
Aesculap Implant System, Inc.2010—

Also cleared against K032476: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 13 years and passes through 6 companies; a new generation was cleared every 9 months on median.
  • 7 of the 62 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K032476.

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. 2014, 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® Lateral VBR System is a partial or total vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to LS5) 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 read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

Also cleared against K032476

5 other devices cite the same predicate.

  • K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated · 2015
  • K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated · 2015
  • K142205NuVasive X-CORE (R) Expandable VBR SystemNuvasive, Inc. · 2015
  • K131724Pioneer Maxfuse Vertebral Body Replacement DevicePioneer Surgical Technology, Inc. · 2013
  • K043405Nuvasive Coroent SystemNuvasive, Inc. · 20051 recall

More from Nu Vasive, Incorporated

112 FDA decisions under this applicant name. See the company

  • K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent…Nu Vasive, Incorporated · 2023
  • K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated · 2023
  • K230989Rod Registration FrameNu Vasive, Incorporated · 2023
  • K223181NuVasive Reline SystemNu Vasive, Incorporated · 2023
  • K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated · 2022

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/K140563 · printed Nov 5, 2026

Cite this page

510(k) Report. “K140563: Lateral VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140563

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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