510(k) Report

510(k) · Cleared

Cleared

Xpand Corpectomy Spacer

K050850510(k) SpecialCleared May 26, 200552-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 May 26, 2005 as substantially equivalent to K031302 (Globus Medical, Inc., 2003) after a 52-day review. Its family tree reaches back 4 generations to 2001. 284 later devices descend from it.

Decided
May 26, 2005
Review
52 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K003275 (2001). 284 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2018: 9 descendants cleared2011: 2 descendants cleared2014: 3 descendants cleared2019: 16 descendants cleared2012: 3 descendants cleared2020: 19 descendants cleared2016: 2 descendants cleared2017: 11 descendants cleared2015: 1 descendant cleared2021: 18 descendants cleared2023: 40 descendants cleared2022: 27 descendants cleared2024: 49 descendants cleared2026: 37 descendants cleared2025: 45 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) 200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 17 descendants3 generations forward: 29 descendants4 generations forward: 48 descendants5 generations forward: 68 descendants6 generations forward: 65 descendants7 generations forward: 26 descendants8 generations forward: 16 descendants9 generations forward: 8 descendants10 generations forward: 1 descendant11 generations forward: 1 descendant K031302 · 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 · recalled0+5+10
  1. Root · 4 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
  2. 3 generations backK020152 Synthes Vertebral Spacer TISynthes (Usa) · 2002
  3. 2 generations backK024364 Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003
  4. 1 generation backK031302 Sustain SpacerGlobus Medical, Inc. · 2003
  5. This deviceK050850 Xpand Corpectomy SpacerGlobus Medical, Inc. · 2005
  6. Descendant · cites it directly · 274 of its ownK060665 Xpand Radiolucent Corpectomy SpacerGlobus Medical, Inc. · 2006
  7. Descendant · cites it directly · 268 of its ownK112756 Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011
  8. Descendant · 2 generations on · 214 of its ownK121107 Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc. · 2012
  9. Descendant · 2 generations on · 210 of its ownK143578 SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer…Globus Medical, Inc. · 2016
  10. Descendant · 2 generations on · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017

Showing 5 of 284 descendants. See all descendants

Descendants cleared per year

2006: 22011: 22012: 32014: 32015: 12016: 22017: 112018: 92019: 162020: 192021: 182022: 272023: 402024: 492025: 452026: 37
2006high 49 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 284 · See all
  • K060665Xpand Radiolucent Corpectomy SpacerGlobus Medical, Inc. · 2006 · cites it directly274descendants
  • K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011 · cites it directly268descendants
  • K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc. · 2012 · 2 generations on214descendants
  • K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc. · 2016 · 2 generations on210descendants
  • K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · 2 generations on149descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K003275Synthes Synmesh Spacer SystemSynthes (Usa)200114
−3K020152Synthes Vertebral Spacer TISynthes (Usa)2002—
−2K024364Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa)2003—
−1K031302Sustain SpacerGlobus Medical, Inc.2003—
0 (this device)K050850Xpand Corpectomy SpacerGlobus Medical, Inc.2005—
+1K060665Xpand Radiolucent Corpectomy SpacerGlobus Medical, Inc.2006—
+1K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011—
+2K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012—
+2K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS…Globus Medical, Inc.2016—
+2K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers…Globus Medical, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
201120
201230
201430
201510
201620
2017110
201890
2019160
2020190
2021180
2022270
2023400
2024490
2025450
2026370
FIG. 1 — Lineage of K050850, 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
*K031302Sustain Spacer
Summary page 1
…ant, fixation, spinal intervertebral body fixation orthosis devices. Class II. T'he Product Code is MQP. The Panel Code is 87. PREDICATE DEVICES: Globus Sustain Spacer K031302, SE date June 27, 2003 DEVICE DESCRIPTION: T'he XPAND CORPECTOMY SPACER is a vertebral body replacement device used to provide…
Globus Medical, Inc.2003—

Also cleared against K031302: 2 other devices →

What descends from it? (284)

See all 284

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

NumberDeviceApplicantDecidedDescendants
K060665Xpand Radiolucent Corpectomy SpacerGlobus Medical, Inc.2006274
K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268
K060416Obelisc Vertebral Body Replacement DeviceUlrich GmbH & Co. KG200656
K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448
K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188

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 4 years and passes through 2 companies; a new generation was cleared every 12 months on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K060665 (Globus Medical, Inc., 2006) has gone furthest, with 274 descendants of its own.
  • 2 other devices also cite its predicate K031302.

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.

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 XPAND 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 XPAND 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 XPAND 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 K031302

2 other devices cite the same predicate.

  • K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc. · 2013
  • K040284Sustain Radiolucent SpacerGlobus Medical, Inc. · 2004

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/K050850 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050850: Xpand Corpectomy Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050850

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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