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 · MQP Spinal Vertebral Body Replacement Device
Cleared on Jun 24, 2004 as substantially equivalent to K030736 (Medtronic Sofamor Danek, 2003) and 3 other predicates after a 23-day review. Its family tree reaches back 5 generations to 2001. 1 of the 826 devices in its family, counting itself, has a Class I recall. 815 later devices descend from it.
- Decided
- Jun 24, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K003155 (2001). 10 ancestors in all, the oldest K841189 (1984). 815 later devices descend from it, 4 citing it directly. 1 of the 826 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 4 generations backK012254 VBROsteotech, Inc. · 2001
- 3 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 2 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 1 generation backK030736 Verte-Stack Spinal System, Extra Small SizesMedtronic Sofamor Danek · 2003
- This deviceK041452 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- Descendant · cites it directly · 796 of its ownK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- Descendant · 2 generations on · 761 of its ownK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · cites it directly · 726 of its ownK043566 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2005
- Descendant · 3 generations on · 723 of its ownK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · 2 generations on · 716 of its ownK082342 Modification to Capstone Spinal SystemMedtronic Sofamor Danek · 2008
Showing 5 of 815 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 815 · See all- K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009 · cites it directly796descendants
- K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 2 generations on761descendants
- K043566Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2005 · cites it directly726descendants
- K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 3 generations on723descendants
- K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek · 2008 · 2 generations on716descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −4 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −3 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −2 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −1 | K030736 | Verte-Stack Spinal System, Extra Small Sizes | Medtronic Sofamor Danek | 2003 | — |
| 0 (this device) | K041452 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| +1 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| +2 | K120368 | Capstone Control Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +1 | K043566 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2005 | — |
| +3 | K121760 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +2 | K082342 | Modification to Capstone Spinal System | Medtronic Sofamor Danek | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 9 | 0 |
| 2013 | 9 | 0 |
| 2014 | 16 | 0 |
| 2015 | 15 | 0 |
| 2016 | 33 | 0 |
| 2017 | 51 | 0 |
| 2018 | 56 | 0 |
| 2019 | 67 | 0 |
| 2020 | 78 | 0 |
| 2021 | 70 | 1 |
| 2022 | 72 | 0 |
| 2023 | 89 | 0 |
| 2024 | 94 | 0 |
| 2025 | 76 | 0 |
| 2026 | 66 | 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? (4)
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 |
|---|---|---|---|
| * | K030736 | Verte-Stack Spinal System, Extra Small SizesSummary page 2…d which demonstrated the VERTE-STACKTM Spinal System to be substantially equivalent to the previously cleared VERTE-STACKTM Spinal System components found in K030736, K030735, K023570 and K021791. 1000025 === Page 3 =… | 2003 |
| * | K030735 | Modified Verte-Stack Spinal SystemSummary page 2…emonstrated the VERTE-STACKTM Spinal System to be substantially equivalent to the previously cleared VERTE-STACKTM Spinal System components found in K030736, K030735, K023570 and K021791. 1000025 DE… | 2003 |
| * | K023570 | Modification to Verte-Stack Spinal SystemSummary page 2…ed the VERTE-STACKTM Spinal System to be substantially equivalent to the previously cleared VERTE-STACKTM Spinal System components found in K030736, K030735, K023570 and K021791. 1000025 DEPARTMENT… | 2002 |
| * | K021791 | Verte-Stack Spinal SystemSummary page 2…-STACKTM Spinal System to be substantially equivalent to the previously cleared VERTE-STACKTM Spinal System components found in K030736, K030735, K023570 and K021791. 1000025 DEPARTMENT OF HEALTH &… | 2002 |
What descends from it? (815)
See all 8154 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 7 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 10 ancestors has a recall.
- Of its descendants, K090353 (Medtronic Sofamor Danek, 2009) has gone furthest, with 796 descendants of its own.
- 8 other devices also cite its predicate K030736.
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, the 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/K041452 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041452: 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/K041452
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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