510(k) Report

510(k) · Cleared

Cleared

Lift VB Spinal System

K010930510(k) TraditionalCleared Oct 24, 2001210-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 Oct 24, 2001 after a 210-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 2,054 devices in its family, counting itself, have a Class I recall. 2,053 later devices descend from it.

Decided
Oct 24, 2001
Review
210 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
0

2,053 later devices descend from it, 6 citing it directly. 2 of the 2,054 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2010: 18 descendants cleared2008: 17 descendants cleared2002: 2 descendants cleared2011: 45 descendants cleared2003: 5 descendants cleared2004: 12 descendants cleared2005: 17 descendants cleared, 1 with a Class I recall12007: 9 descendants cleared2017: 166 descendants cleared2014: 116 descendants cleared2019: 145 descendants cleared2013: 89 descendants cleared2006: 19 descendants cleared2012: 69 descendants cleared2009: 18 descendants cleared2018: 152 descendants cleared2022: 125 descendants cleared2020: 145 descendants cleared2015: 115 descendants cleared2024: 133 descendants cleared2023: 160 descendants cleared2016: 129 descendants cleared2021: 127 descendants cleared, 1 with a Class I recall12025: 116 descendants cleared2026: 104 descendants cleared200020052010201520202025
  1. This deviceK010930 Lift VB Spinal SystemMedtronic Sofamor Danek, Inc. · 2001
  2. Descendant · cites it directly · 2,047 of its ownK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  3. Descendant · 2 generations on · 1,383 of its ownK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. Descendant · 2 generations on · 1,326 of its ownK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  5. Descendant · 2 generations on · 1,218 of its ownK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
  6. Descendant · 3 generations on · 1,214 of its ownK043479 MC+ Partial VBRLdr Spine USA · 2005

Showing 5 of 2,053 descendants. See all descendants

Descendants cleared per year

2002: 22003: 52004: 122005: 172006: 192007: 92008: 172009: 182010: 182011: 452012: 692013: 892014: 1162015: 1152016: 1292017: 1662018: 1522019: 1452020: 1452021: 1272022: 1252023: 1602024: 1332025: 1162026: 104
2002high 166 (2017) · low 2 (2002)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 2,053 · See all
  • K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002 · cites it directly2,047descendants
  • K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002 · 2 generations on1,383descendants
  • K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003 · 2 generations on1,326descendants
  • K033109Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004 · 2 generations on1,218descendants
  • K043479MC+ Partial VBRLdr Spine USA · 2005 · 3 generations on1,214descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010930Lift VB Spinal SystemMedtronic Sofamor Danek, Inc.2001—
+1K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
+2K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
+2K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
+2K033109Ellys and Aurys Vertebral Body ReplacementsScient'X2004—
+3K043479MC+ Partial VBRLdr Spine USA2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200350
2004120
2005171
2006190
200790
2008170
2009180
2010180
2011450
2012690
2013890
20141160
20151150
20161290
20171660
20181520
20191450
20201450
20211271
20221250
20231600
20241330
20251160
20261040
FIG. 1 — Lineage of K010930, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2,053)

See all 2,053

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

NumberDeviceApplicantDecidedDescendants
K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek20022,047
K040422Modification to Verte-StackMedtronic Sofamor Danek20041,002
K024049Verte-Span Spinal SystemMedtronic Sofamor Danek, Inc.200373
K083186Aesculap Hydrolift VBR SystemAesculap Implant System, Inc.201051
K110864Biospine VBR SystemAesculap Implant Systems, LLC201149
K081673Dyn-Alif Anterolateral Intervertebral Body Fusion DeviceIonics Medical Corp.20080

Has anything in its family been recalled? (2 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.

  • K051781Graftcage TLXOsteotech, Inc. · 2005 · 4 generations on · ◆ in the 2005 descendants bar of FIG. 11 Class I recall
  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K021791 (Medtronic Sofamor Danek, 2002) has gone furthest, with 2,047 descendants of its own.

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—
Cite this page

510(k) Report. “K010930: Lift VB Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010930

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026