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 Nov 19, 2002 as substantially equivalent to K021791 (Medtronic Sofamor Danek, 2002) after a 26-day review. Its family tree reaches back 3 generations to 2001. 2 of the 1,391 devices in its family, counting itself, have a Class I recall. 1,383 later devices descend from it.
- Decided
- Nov 19, 2002
- Review
- 26 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003155 (2001). 7 ancestors in all, the oldest K841189 (1984). 1,383 later devices descend from it, 8 citing it directly. 2 of the 1,391 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 2 generations backK012254 VBROsteotech, Inc. · 2001
- 1 generation backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- This deviceK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- Descendant · cites it directly · 1,326 of its ownK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- Descendant · cites it directly · 1,151 of its ownK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- Descendant · 2 generations on · 1,150 of its ownK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- Descendant · cites it directly · 1,101 of its ownK030736 Verte-Stack Spinal System, Extra Small SizesMedtronic Sofamor Danek · 2003
- Descendant · 2 generations on · 1,002 of its ownK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
Showing 5 of 1,383 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 1,383 · See all- K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003 · cites it directly1,326descendants
- K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003 · cites it directly1,151descendants
- K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004 · 2 generations on1,150descendants
- K030736Verte-Stack Spinal System, Extra Small SizesMedtronic Sofamor Danek · 2003 · cites it directly1,101descendants
- K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004 · 2 generations on1,002descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −2 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −1 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| 0 (this device) | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| +1 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| +1 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| +2 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| +1 | K030736 | Verte-Stack Spinal System, Extra Small Sizes | Medtronic Sofamor Danek | 2003 | — |
| +2 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
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 |
|---|---|---|
| 2003 | 4 | 0 |
| 2004 | 10 | 0 |
| 2005 | 9 | 1 |
| 2006 | 12 | 0 |
| 2007 | 6 | 0 |
| 2008 | 9 | 0 |
| 2009 | 7 | 0 |
| 2010 | 10 | 0 |
| 2011 | 25 | 0 |
| 2012 | 29 | 0 |
| 2013 | 38 | 0 |
| 2014 | 65 | 0 |
| 2015 | 60 | 0 |
| 2016 | 84 | 0 |
| 2017 | 116 | 0 |
| 2018 | 100 | 0 |
| 2019 | 109 | 0 |
| 2020 | 110 | 0 |
| 2021 | 94 | 1 |
| 2022 | 92 | 0 |
| 2023 | 114 | 0 |
| 2024 | 107 | 0 |
| 2025 | 89 | 0 |
| 2026 | 84 | 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.
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 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 |
|---|---|---|---|
| * | K021791 | Verte-Stack Spinal System | 2002 |
What descends from it? (1,383)
See all 1,3838 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031780 | Verte-Stack Spinal System | 2003 | 1,326 |
| K030601 | Verte-Stack Spinal System | 2003 | 1,151 |
| K030736 | Verte-Stack Spinal System, Extra Small Sizes | 2003 | 1,101 |
| K030735 | Modified Verte-Stack Spinal System | 2003 | 816 |
| K041452 | Modification to Verte-Stack Spinal System | 2004 | 815 |
| K131082 | Interform Interbody Cage System | 2013 | 595 |
| K063637 | Reliance VBS System | 2007 | 1 |
| K081383 | Reliance VBS System | 2008 | 0 |
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.
What does this lineage say?
- The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 9 months on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K031780 (Medtronic Sofamor Danek, 2003) has gone furthest, with 1,326 descendants of its own.
- 11 other devices also cite its predicate K021791.
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-STACKTMSpinal 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-STACKTMSpinal System is to be used with supplemental fixation. Specifically, the VERTE-STACKTMdevice is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, Titanium DYNALOKTMCLASSIC Spinal System, Laurain DeWald Anterior Fixation System, Titanium TSRHB Spinal System Titanium CD HORIZONB Spinal System, the Titanium GDLHB Spinal System, or their successors Additionally, the VERTE-STACKTMdevice is intended to be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023570: 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/K023570
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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