510(k) Report

510(k) · Cleared

Cleared

Verte-Stack Spinal System

K061938510(k) SpecialCleared Aug 9, 200630-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

Medtronic Sofamor Danek, Inc. · MQP Spinal Vertebral Body Replacement Device

Cleared on Aug 9, 2006 as substantially equivalent to K060719 (Medtronic Sofamor Danek, 2006) and 2 other predicates after a 30-day review. Its family tree reaches back 9 generations to 2001. 152 later devices descend from it.

Decided
Aug 9, 2006
Review
30 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
3

Its longest line of descent runs back 9 generations to K003155 (2001). 18 ancestors in all, the oldest K841189 (1984). 152 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2003: 2 other ancestors2004: 2 other ancestors2001: 2 other ancestors2000: 1 other ancestor1984: 1 other ancestor2006: 1 descendant cleared2007: 1 descendant cleared2013: 5 descendants cleared2011: 2 descendants cleared2009: 1 descendant cleared2018: 8 descendants cleared2017: 12 descendants cleared2008: 1 descendant cleared2016: 6 descendants cleared2012: 5 descendants cleared2025: 12 descendants cleared2014: 9 descendants cleared2026: 13 descendants cleared2022: 9 descendants cleared2021: 8 descendants cleared2023: 16 descendants cleared2020: 16 descendants cleared2019: 6 descendants cleared2015: 8 descendants cleared2024: 13 descendants 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 · 2004K060719 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 6 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 6 descendants4 generations forward: 19 descendants5 generations forward: 23 descendants6 generations forward: 27 descendants7 generations forward: 22 descendants8 generations forward: 19 descendants9 generations forward: 14 descendants10 generations forward: 12 descendants11 generations forward: 6 descendants12 generations forward: 2 descendants K060719 · 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. · 2001−50+5+10
  1. Root · 9 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 5 generations between
  3. 3 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  4. 2 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  5. 1 generation backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  6. This deviceK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  7. Descendant · cites it directly · 151 of its ownK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  8. Descendant · 2 generations on · 150 of its ownK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  9. Descendant · 3 generations on · 106 of its ownK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  10. Descendant · 4 generations on · 102 of its ownK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  11. Descendant · 5 generations on · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
Show all 9 generations
  1. Root · 9 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 8 generations backK012254 VBROsteotech, Inc. · 2001
  3. 7 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 6 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 5 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 4 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 3 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 2 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 1 generation backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. This deviceK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006

Showing 5 of 152 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12008: 12009: 12011: 22012: 52013: 52014: 92015: 82016: 62017: 122018: 82019: 62020: 162021: 82022: 92023: 162024: 132025: 122026: 13
2006high 16 (2020) · low 0 (2010)2026

Most influential descendants

Showing 5 of 152 · See all
  • K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006 · cites it directly151descendants
  • K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007 · 2 generations on150descendants
  • K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 3 generations on106descendants
  • K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · 4 generations on102descendants
  • K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 5 generations on75descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−8K012254VBROsteotech, Inc.2001—
−7K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−6K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−5K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−4K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−3K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−2K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−1K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
0 (this device)K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006—
+1K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
+2K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007—
+3K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011—
+4K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)20132

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
200010
200120
200320
200420
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200810
200910
201120
201250
201350
201490
201580
201660
2017120
201880
201960
2020160
202180
202290
2023160
2024130
2025120
2026130
FIG. 1 — Lineage of K061938, 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? (3)

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
*K060719Modification to Verte-Stack Spinal System
Summary page 2
…which demonstrated that the subject VERTE-STACK® Spinal System components are substantially equivalent to the previously cleared VERTE-STACK® Spinal System (K060719, SE 4/12/2006; K052931, SE 11/13/2005; and K030736, SE 4/2/2003). DEPARTMENT OF HEALTH & HUMAN SERVI…
Medtronic Sofamor Danek2006—
*K052931Modification to Verte-Stack Spinal System
Summary page 2
…the subject VERTE-STACK® Spinal System components are substantially equivalent to the previously cleared VERTE-STACK® Spinal System (K060719, SE 4/12/2006; K052931, SE 11/13/2005; and K030736, SE 4/2/2003). DEPARTMENT OF HEALTH & HUMAN SERVICES…
Medtronic Sofamor Danek2005—
*K030736Verte-Stack Spinal System, Extra Small Sizes
Summary page 2
…pinal System components are substantially equivalent to the previously cleared VERTE-STACK® Spinal System (K060719, SE 4/12/2006; K052931, SE 11/13/2005; and K030736, SE 4/2/2003). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Healt…
Medtronic Sofamor Danek2003—

Also cleared against K060719: 3 other devices →

What descends from it? (152)

See all 152

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

NumberDeviceApplicantDecidedDescendants
K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006151

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 5 years and passes through 3 companies; a new generation was cleared every 6 months on median.
  • None of the 18 ancestors has a recall.
  • Of its descendants, K062427 (Medtronic Sofamor Danek, 2006) has gone furthest, with 151 descendants of its own.
  • 3 other devices also cite its predicate K060719.

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 VERTE-STACK® Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE 1I Anterior Fixation System, DYNALOK TM CLASSIC Spinal System, the VANTAGE TM Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK® device is intended to be used with bone graft.

Indications for use as stated in the FDA summary.

Also cleared against K060719

3 other devices cite the same predicate.

  • K063491T2 Sceptor Spinal SystemMedtronic Sofamor Danek · 2007
  • K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
  • K062073Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006

More from Medtronic Sofamor Danek, Inc.

125 FDA decisions under this applicant name. See the company

  • K251193Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone GraftMedtronic Sofamor Danek, Inc. · 2025
  • K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc. · 2025
  • K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc. · 2023
  • P060018/S005Prestige Cervical Disc SystemMedtronic Sofamor Danek, Inc. · 2016
  • P060018/S004PRESTIGE® Cervical DiscMedtronic Sofamor Danek, Inc. · 2016

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/K061938 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061938: Verte-Stack Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061938

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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