510(k) Report

510(k) · Cleared

Cleared

Niko Corpectomy Spacer

K072465510(k) SpecialCleared Oct 4, 200730-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

Globus Medical, Inc. · MQP Spinal Vertebral Body Replacement Device

Cleared on Oct 4, 2007 as substantially equivalent to K040284 (Globus Medical, Inc., 2004) after a 30-day review. Its family tree reaches back 5 generations to 2001. 327 later devices descend from it.

Decided
Oct 4, 2007
Review
30 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K003275 (2001). 327 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2016: 3 descendants cleared2012: 1 descendant cleared2015: 3 descendants cleared2017: 12 descendants cleared2013: 1 descendant cleared2018: 14 descendants cleared2021: 27 descendants cleared2023: 45 descendants cleared2019: 15 descendants cleared2020: 28 descendants cleared2014: 2 descendants cleared2026: 41 descendants cleared2022: 36 descendants cleared2025: 48 descendants cleared2024: 51 descendants clearedK003275 · Synthes Synmesh Spacer System · Synthes (Usa) · 2001 · recalledK020152 · Synthes Vertebral Spacer TI · Synthes (Usa) · 2002×2: 2 generations cleared close together, K024364 (2003), K031302 (2003) K040284 · Sustain Radiolucent Spacer · Globus Medical, Inc. · 2004200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 17 descendants3 generations forward: 56 descendants4 generations forward: 89 descendants5 generations forward: 84 descendants6 generations forward: 37 descendants7 generations forward: 15 descendants8 generations forward: 14 descendants9 generations forward: 8 descendants10 generations forward: 1 descendant11 generations forward: 1 descendant K040284 · Sustain Radiolucent Spacer · Globus Medical, Inc. · 2004K031302 · Sustain Spacer · Globus Medical, Inc. · 2003K024364 · Synthes Vertebral Spacer TI (Curved and Narrow) · Synthes (Usa) · 2003K020152 · Synthes Vertebral Spacer TI · Synthes (Usa) · 2002K003275 · Synthes Synmesh Spacer System · Synthes (Usa) · 2001 · recalled−50+5+10
  1. Root · 5 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
  2. 4 generations backK020152 Synthes Vertebral Spacer TISynthes (Usa) · 2002
  3. 3 generations backK024364 Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003
  4. 2 generations backK031302 Sustain SpacerGlobus Medical, Inc. · 2003
  5. 1 generation backK040284 Sustain Radiolucent SpacerGlobus Medical, Inc. · 2004
  6. This deviceK072465 Niko Corpectomy SpacerGlobus Medical, Inc. · 2007
  7. Descendant · cites it directly · 322 of its ownK120570 Choice Spine Vertebral Body Replacement (VBR) Device SystemChoicespine, LP · 2012
  8. Descendant · 2 generations on · 251 of its ownK130573 Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC · 2013
  9. Descendant · 3 generations on · 227 of its ownK133967 Interbody Cage SystemAurora Spine · 2014
  10. Descendant · cites it directly · 210 of its ownK143578 SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer…Globus Medical, Inc. · 2016
  11. Descendant · cites it directly · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017

Showing 5 of 327 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12014: 22015: 32016: 32017: 122018: 142019: 152020: 282021: 272022: 362023: 452024: 512025: 482026: 41
2012high 51 (2024) · low 1 (2012)2026

Most influential descendants

Showing 5 of 327 · See all
  • K120570Choice Spine Vertebral Body Replacement (VBR) Device SystemChoicespine, LP · 2012 · cites it directly322descendants
  • K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC · 2013 · 2 generations on251descendants
  • K133967Interbody Cage SystemAurora Spine · 2014 · 3 generations on227descendants
  • K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc. · 2016 · cites it directly210descendants
  • K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · cites it directly149descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K003275Synthes Synmesh Spacer SystemSynthes (Usa)200114
−4K020152Synthes Vertebral Spacer TISynthes (Usa)2002—
−3K024364Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa)2003—
−2K031302Sustain SpacerGlobus Medical, Inc.2003—
−1K040284Sustain Radiolucent SpacerGlobus Medical, Inc.2004—
0 (this device)K072465Niko Corpectomy SpacerGlobus Medical, Inc.2007—
+1K120570Choice Spine Vertebral Body Replacement (VBR) Device SystemChoicespine, LP2012—
+2K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013—
+3K133967Interbody Cage SystemAurora Spine2014—
+1K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS…Globus Medical, Inc.2016—
+1K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers…Globus Medical, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201420
201530
201630
2017120
2018140
2019150
2020280
2021270
2022360
2023450
2024510
2025480
2026410
FIG. 1 — Lineage of K072465, 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? (1)

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
*K040284Sustain Radiolucent Spacer
Summary page 1
…, fixation, spinal intervertebral body fixation orthosis devices. Class II.The Product Code is MQP. The Panel Code is 87. PREDICATE DEVICES: Sustain Radiolucent Spacer K040284; SE date March 23, 2004 DEVICE DESCRIPTION: The NIKOTM Corpectomy Spacer device is a vertebral body replacement device used to…
Globus Medical, Inc.2004—

Also cleared against K040284: 9 other devices →

What descends from it? (327)

See all 327

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

NumberDeviceApplicantDecidedDescendants
K120570Choice Spine Vertebral Body Replacement (VBR) Device SystemChoicespine, LP2012322
K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210
K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149
K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755
K143490VERTA Corpectomy CageCamber Spine20151

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 6 years and passes through 2 companies; a new generation was cleared every 11 months on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K120570 (Choicespine, LP, 2012) has gone furthest, with 322 descendants of its own.
  • 9 other devices also cite its predicate K040284.

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. 2007, 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 NIKOTM Corpectomy Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The NIKO TM Corpectomy Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.

The NIKOTM Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Indications for use as stated in the FDA summary.

Also cleared against K040284

9 other devices cite the same predicate.

  • K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™…Globus Medical, Inc. · 2017
  • K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS…Globus Medical, Inc. · 2016
  • K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc. · 2013
  • K061380Retain Radiolucent SpacerGlobus Medical, Inc. · 2006
  • K060916Atlas Spinal Cage, Models SC-150-007, 009, 011, 013, 015, 017.Spinal Edge, LLC · 2006
  • K060665Xpand Radiolucent Corpectomy SpacerGlobus Medical, Inc. · 2006

More from Globus Medical, Inc.

184 FDA decisions under this applicant name. See the company

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc. · 2026
  • K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System…Globus Medical, Inc. · 2026
  • K253401SCRIPT™ Implant SystemGlobus Medical, Inc. · 2026

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/K072465 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072465: Niko Corpectomy Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072465

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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