510(k) Report

510(k) · Cleared

Cleared

Modification to Verte-Stack Spinal System

K041197510(k) SpecialCleared Aug 9, 200494-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 · MQP Spinal Vertebral Body Replacement Device

Cleared on Aug 9, 2004 as substantially equivalent to K030736 (Medtronic Sofamor Danek, 2003) after a 94-day review. Its family tree reaches back 5 generations to 2001. 1 of the 1,004 devices in its family, counting itself, has a Class I recall. 994 later devices descend from it.

Decided
Aug 9, 2004
Review
94 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K003155 (2001). 9 ancestors in all, the oldest K841189 (1984). 994 later devices descend from it, 3 citing it directly. 1 of the 1,004 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2000: 1 other ancestor1984: 1 other ancestor2011: 10 descendants cleared2010: 4 descendants cleared2005: 1 descendant cleared2007: 4 descendants cleared2006: 5 descendants cleared2017: 70 descendants cleared2019: 76 descendants cleared2015: 31 descendants cleared2013: 13 descendants cleared2020: 97 descendants cleared2012: 8 descendants cleared2026: 77 descendants cleared2016: 46 descendants cleared2014: 22 descendants cleared2008: 3 descendants cleared2009: 2 descendants cleared2018: 69 descendants cleared2023: 105 descendants cleared2021: 83 descendants cleared, 1 with a Class I recall12022: 81 descendants cleared2024: 101 descendants cleared2025: 86 descendants clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×3: 3 generations cleared close together, K021791 (2002), K023570 (2002), K030736 (2003) 19801990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 4 other ancestors 1 generation forward: 3 descendants2 generations forward: 21 descendants3 generations forward: 50 descendants4 generations forward: 78 descendants5 generations forward: 99 descendants6 generations forward: 165 descendants, 1 with a Class I recall17 generations forward: 199 descendants8 generations forward: 156 descendants9 generations forward: 119 descendants10 generations forward: 59 descendants11 generations forward: 28 descendants12 generations forward: 13 descendants13 generations forward: 4 descendants K030736 · Verte-Stack Spinal System, Extra Small Sizes · 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 · 5 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 4 generations backK012254 VBROsteotech, Inc. · 2001
  3. 3 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 2 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 1 generation backK030736 Verte-Stack Spinal System, Extra Small SizesMedtronic Sofamor Danek · 2003
  6. This deviceK041197 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. Descendant · cites it directly · 993 of its ownK052931 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2005
  8. Descendant · 2 generations on · 992 of its ownK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  9. Descendant · 2 generations on · 844 of its ownK062073 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. Descendant · 3 generations on · 710 of its ownK082732 Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. Descendant · 4 generations on · 709 of its ownK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013

Showing 5 of 994 descendants. See all descendants

Descendants cleared per year

2005: 12006: 52007: 42008: 32009: 22010: 42011: 102012: 82013: 132014: 222015: 312016: 462017: 702018: 692019: 762020: 972021: 832022: 812023: 1052024: 1012025: 862026: 77
2005high 105 (2023) · low 1 (2005)2026

Class I recalls in this family

  • K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 994 · See all
  • K052931Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2005 · cites it directly993descendants
  • K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006 · 2 generations on992descendants
  • K062073Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006 · 2 generations on844descendants
  • K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008 · 3 generations on710descendants
  • K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013 · 4 generations on709descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−4K012254VBROsteotech, Inc.2001—
−3K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−2K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−1K030736Verte-Stack Spinal System, Extra Small SizesMedtronic Sofamor Danek2003—
0 (this device)K041197Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
+1K052931Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2005—
+2K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
+2K062073Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
+3K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
+4K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
200010
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200650
200740
200830
200920
201040
2011100
201280
2013130
2014220
2015310
2016460
2017700
2018690
2019760
2020970
2021831
2022810
20231050
20241010
2025860
2026770
FIG. 1 — Lineage of K041197, 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.

1 device in this family has a Class I recall. 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
*K030736Verte-Stack Spinal System, Extra Small Sizes
Summary page 2
…Spinal System to be substantially equivalent to the previously cleared VERTE-STACKTM (K030736, SE 04/02/03). 000026…
Medtronic Sofamor Danek2003—

Also cleared against K030736: 8 other devices →

What descends from it? (994)

See all 994

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

NumberDeviceApplicantDecidedDescendants
K052931Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2005993
K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389
K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 9 months on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K052931 (Medtronic Sofamor Danek, 2005) has gone furthest, with 993 descendants of its own.
  • 8 other devices also cite its predicate K030736.

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 (T1-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 II Anterior Fixation System, DYNALOK CLASSIC Spinal System, the VANTAGE 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 K030736

8 other devices cite the same predicate.

  • K111294Santorini Spinal SystemK2m, Inc. · 2012
  • K081383Reliance VBS SystemReliance Medical Systems, LLC · 2008
  • K063637Reliance VBS SystemReliance Medical Systems, LLC · 2007
  • K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  • K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  • K052931Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2005

More from Medtronic Sofamor Danek

154 FDA decisions under this applicant name. See the company

  • K212428Centerpiece Plate Fixation SystemMedtronic Sofamor Danek · 2021
  • K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
  • K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek · 2017
  • K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System TitaniumMedtronic Sofamor Danek · 2017
  • K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek · 2017

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/K041197 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041197: Modification to 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/K041197

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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