510(k) Report

510(k) · Cleared

Cleared

NuVasive PEEK Corpectomy Railed System

K151538510(k) TraditionalCleared Sep 4, 201588-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 Sep 4, 2015 as substantially equivalent to K032476 (Nuvasive, Inc., 2003) and 4 other predicates after an 88-day review. Its family tree reaches back 11 generations to 2001. 13 later devices descend from it.

Decided
Sep 4, 2015
Review
88 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
5

Its longest line of descent runs back 11 generations to K003155 (2001). 27 ancestors in all, the oldest K841189 (1984). 13 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2005: 2 other ancestors2003: 3 other ancestors2009: 1 other ancestor2006: 1 other ancestor2001: 3 other ancestors2004: 2 other ancestors2000: 1 other ancestor1999: 1 other ancestor1984: 1 other ancestor2017: 1 descendant cleared2018: 1 descendant cleared2019: 2 descendants cleared2020: 2 descendants cleared2026: 3 descendants cleared2024: 3 descendants cleared2023: 1 descendant clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×3: 3 generations cleared close together, K021791 (2002), K023570 (2002), K030601 (2003) ×2: 2 generations cleared close together, K040536 (2004), K041556 (2004) K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004×3: 3 generations cleared close together, K060719 (2006), K062133 (2006), K070173 (2007) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors3 generations back: 4 other ancestors4 generations back: 2 other ancestors5 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 4 descendants4 generations forward: 4 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant K070173 · Verte-Stack Spinal System · Medtronic Sofamor Danek, Inc. · 2007K062133 · Modification to Verte-Stack Spinal System · Medtronic Spinal and Biologics Div · 2006K060719 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K041556 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K040536 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K030601 · 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+5
  1. Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 7 generations between
  3. 3 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  4. 2 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
  5. 1 generation backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
  6. This deviceK151538 NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated · 2015
  7. Descendant · cites it directly · 12 of its ownK170271 NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated · 2017
  8. Descendant · 2 generations on · 11 of its ownK180550 NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated · 2018
  9. Descendant · 3 generations on · 5 of its ownK191778 Omnia Medical VBROmnia Medical, LLC · 2019
  10. Descendant · 3 generations on · 3 of its ownK190426 ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC · 2019
  11. Descendant · 4 generations on · 2 of its ownK233359 DOMINION Expandable Corpectomy SystemAstura Medical · 2024
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 backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 6 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 5 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 4 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 3 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 2 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
  11. 1 generation backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
  12. This deviceK151538 NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated · 2015

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2017: 12018: 12019: 22020: 22023: 12024: 32026: 3
2017high 3 (2024) · low 0 (2021)2026

Most influential descendants

Showing 5 of 13 · See all
  • K170271NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated · 2017 · cites it directly12descendants
  • K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated · 2018 · 2 generations on11descendants
  • K191778Omnia Medical VBROmnia Medical, LLC · 2019 · 3 generations on5descendants
  • K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC · 2019 · 3 generations on3descendants
  • K233359DOMINION Expandable Corpectomy SystemAstura Medical · 2024 · 4 generations on2descendants
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—
−7K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−6K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−5K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−4K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−3K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−2K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div2006—
−1K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007—
0 (this device)K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated2015—
+1K170271NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated2017—
+2K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated2018—
+3K191778Omnia Medical VBROmnia Medical, LLC2019—
+3K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC2019—
+4K233359DOMINION Expandable Corpectomy SystemAstura Medical2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199910
200010
200130
200330
200420
200520
200610
200910
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
201920
202020
202310
202430
202630
FIG. 1 — Lineage of K151538, 2001–2026Source: 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? (5)

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
…MQP C. Predicate Devices The subject PEEK Corpectomy Railed System is substantially equivalent to a primary predicate device, NuVasive Mesh (K032476), and additional predicate devices, NuVasive X- Core® Expandable VBR System (K142205), Osteotech VBR (K012254), Medtronic Ve…
Nuvasive, Inc.2003—
*K142205NuVasive X-CORE (R) Expandable VBR System
Summary page 4
…is substantially equivalent to a primary predicate device, NuVasive Mesh (K032476), and additional predicate devices, NuVasive X- Core® Expandable VBR System (K142205), Osteotech VBR (K012254), Medtronic Verte- Stack® Spinal System (K070173), and Novel VBR Spinal System (K050553). D. Dev…
Nuvasive, Inc.2015—
*K012254VBR
Summary page 4
…ent to a primary predicate device, NuVasive Mesh (K032476), and additional predicate devices, NuVasive X- Core® Expandable VBR System (K142205), Osteotech VBR (K012254), Medtronic Verte- Stack® Spinal System (K070173), and Novel VBR Spinal System (K050553). D. Device Description The…
Osteotech, Inc.2001—
*K070173Verte-Stack Spinal System
Summary page 4
…(K032476), and additional predicate devices, NuVasive X- Core® Expandable VBR System (K142205), Osteotech VBR (K012254), Medtronic Verte- Stack® Spinal System (K070173), and Novel VBR Spinal System (K050553). D. Device Description The NuVasive PEEK Corpectomy Railed System is a vertebral…
Medtronic Sofamor Danek, Inc.2007—
*K050553Novel VBR Spinal System
Summary page 4
…ices, NuVasive X- Core® Expandable VBR System (K142205), Osteotech VBR (K012254), Medtronic Verte- Stack® Spinal System (K070173), and Novel VBR Spinal System (K050553). D. Device Description The NuVasive PEEK Corpectomy Railed System is a vertebral body replacement system manufactur…
Alphatec/Nexmed20051

Also cleared against K032476: 5 other devices →

What descends from it? (13)

See all 13

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K170271NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated201712

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 14 years and passes through 5 companies; a new generation was cleared every 6 months on median.
  • 3 of the 27 ancestors have a recall of any class.
  • Of its descendants, K170271 (Nu Vasive, Incorporated, 2017) has gone furthest, with 12 descendants of its own.
  • 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. 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® PEEK Corpectomy Railed System is a partial or total 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 PEEK Corpectomy Railed 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.

Also cleared against K032476

5 other devices cite the same predicate.

  • K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated · 2015
  • K142205NuVasive X-CORE (R) Expandable VBR SystemNuvasive, Inc. · 2015
  • K140563Lateral VBR SystemNu Vasive, Incorporated · 2014
  • 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/K151538 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151538: NuVasive PEEK Corpectomy Railed System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151538

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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