510(k) · Cleared
ClearedModification to: Verte-Stack Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Oct 7, 2005 as substantially equivalent to K040536 (Medtronic Sofamor Danek, 2004) and 2 other predicates after a 49-day review. Its family tree reaches back 6 generations to 2001. 1 of the 850 devices in its family, counting itself, has a Class I recall. 839 later devices descend from it.
- Decided
- Oct 7, 2005
- Review
- 49 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K003155 (2001). 10 ancestors in all, the oldest K841189 (1984). 839 later devices descend from it, 1 citing it directly. 1 of the 850 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 5 generations backK012254 VBROsteotech, Inc. · 2001
- 4 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 3 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 2 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 1 generation backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- This deviceK052261 Modification to: Verte-Stack Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- Descendant · cites it directly · 838 of its ownK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · 2 generations on · 808 of its ownK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- Descendant · 2 generations on · 761 of its ownK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · 2 generations on · 723 of its ownK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · 3 generations on · 709 of its ownK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
Showing 5 of 839 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 839 · See all- K094025Crescent Spinal SystemMedtronic Sofamor Danek · 2010 · cites it directly838descendants
- K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011 · 2 generations on808descendants
- K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 2 generations on761descendants
- K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 2 generations on723descendants
- K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013 · 3 generations on709descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −5 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −4 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −3 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −2 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −1 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| 0 (this device) | K052261 | Modification to: Verte-Stack Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| +1 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +2 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| +2 | K120368 | Capstone Control Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +2 | K121760 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +3 | K123027 | Capstone (R) Spinal System | Medtronic Sofamor Danek, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 10 | 0 |
| 2014 | 16 | 0 |
| 2015 | 18 | 0 |
| 2016 | 35 | 0 |
| 2017 | 57 | 0 |
| 2018 | 63 | 0 |
| 2019 | 75 | 0 |
| 2020 | 83 | 0 |
| 2021 | 71 | 1 |
| 2022 | 73 | 0 |
| 2023 | 91 | 0 |
| 2024 | 95 | 0 |
| 2025 | 76 | 0 |
| 2026 | 69 | 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.
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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040536 | Modification to Verte-Stack Spinal SystemSummary page 2…ed which demonstrated the VERTE-STACK®D Spinal System to be substantially equivalent to the previously cleared VERTE-STACK® Spinal System components found in K040536 (SE 05/05/04), K03060 1 (SE 03/25/03) and in K02 179 1.… | 2004 |
| * | K030601 | Verte-Stack Spinal SystemSummary page 2…he VERTE-STACK®D Spinal System to be substantially equivalent to the previously cleared VERTE-STACK® Spinal System components found in K040536 (SE 05/05/04), K03060 1 (SE 03/25/03) and in K02 179 1. ;% j3?… | 2003 |
| * | K021791 | Verte-Stack Spinal SystemSummary page 2…to be substantially equivalent to the previously cleared VERTE-STACK® Spinal System components found in K040536 (SE 05/05/04), K03060 1 (SE 03/25/03) and in K02 179 1. ;% j3?… | 2002 |
What descends from it? (839)
See all 8391 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K094025 | Crescent Spinal System | 2010 | 838 |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K094025 (Medtronic Sofamor Danek, 2010) has gone furthest, with 838 descendants of its own.
- 6 other devices also cite its predicate K040536.
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-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.
https://510kreport.com/device/K052261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052261: Modification to: Verte-Stack 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/K052261
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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