510(k) · Cleared
ClearedVerte-Span Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Feb 26, 2003 as substantially equivalent to K010930 (Medtronic Sofamor Danek, Inc., 2001) after a 79-day review. Its family tree reaches back 1 generation to 2001. 73 later devices descend from it.
- Decided
- Feb 26, 2003
- Review
- 79 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010930 (2001). 73 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK010930 Lift VB Spinal SystemMedtronic Sofamor Danek, Inc. · 2001
- This deviceK024049 Verte-Span Spinal SystemMedtronic Sofamor Danek, Inc. · 2003
- Descendant · cites it directly · 50 of its ownK071033 T2 XVBR Spinal SystemMedtronic Sofamor Danek · 2007
- Descendant · cites it directly · 49 of its ownK110864 Biospine VBR SystemAesculap Implant Systems, LLC · 2011
- Descendant · 2 generations on · 49 of its ownK100976 T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- Descendant · 2 generations on · 48 of its ownK133802 Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014
- Descendant · 2 generations on · 47 of its ownK173125 T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek · 2017
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 73 · See all- K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek · 2007 · cites it directly50descendants
- K110864Biospine VBR SystemAesculap Implant Systems, LLC · 2011 · cites it directly49descendants
- K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010 · 2 generations on49descendants
- K133802Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014 · 2 generations on48descendants
- K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek · 2017 · 2 generations on47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010930 | Lift VB Spinal System | Medtronic Sofamor Danek, Inc. | 2001 | — |
| 0 (this device) | K024049 | Verte-Span Spinal System | Medtronic Sofamor Danek, Inc. | 2003 | — |
| +1 | K071033 | T2 XVBR Spinal System | Medtronic Sofamor Danek | 2007 | — |
| +1 | K110864 | Biospine VBR System | Aesculap Implant Systems, LLC | 2011 | — |
| +2 | K100976 | T2 XVBR 1.5 Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| +2 | K133802 | Ais Modulift VBR System | Aesculap Implant System, Inc. | 2014 | — |
| +2 | K173125 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 10 | 0 |
| 2025 | 10 | 0 |
| 2026 | 16 | 0 |
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 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010930 | Lift VB Spinal System | 2001 |
What descends from it? (73)
See all 733 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The VERTE-SPAN Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (Tl-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-SPAN Spinal System is to be used with supplemental fixation. Specifically, the VERTE-SPAN device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, Titanium DYNALOK CLASSIC Spinal System, LAURAIN DEWALD Anterior Fixation System, Titanium TSRHB Spinal System, Titanium CD HORIZON Spinal System or the Titanium GDLH Spinal System. Additionally, the VERTE-SPAN device is intended to be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024049 · printed Nov 4, 2026
Cite this page
510(k) Report. “K024049: Verte-Span Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K024049
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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