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 Dec 29, 2004 as substantially equivalent to K041556 (Medtronic Sofamor Danek, 2004) and 1 other predicate after a 2-day review. Its family tree reaches back 7 generations to 2001. 1 of the 1,013 devices in its family, counting itself, has a Class I recall. 999 later devices descend from it.
- Decided
- Dec 29, 2004
- Review
- 2 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K003155 (2001). 13 ancestors in all, the oldest K841189 (1984). 999 later devices descend from it, 2 citing it directly. 1 of the 1,013 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 6 generations backK012254 VBROsteotech, Inc. · 2001
- 5 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 4 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 3 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 2 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 1 generation backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- This deviceK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- Descendant · cites it directly · 992 of its ownK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- Descendant · 2 generations on · 844 of its ownK062073 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- Descendant · cites it directly · 716 of its ownK082342 Modification to Capstone Spinal SystemMedtronic Sofamor Danek · 2008
- Descendant · 2 generations on · 710 of its ownK082732 Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- Descendant · 3 generations on · 709 of its ownK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
Showing 5 of 999 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 999 · See all- K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006 · cites it directly992descendants
- K062073Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006 · 2 generations on844descendants
- K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek · 2008 · cites it directly716descendants
- K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008 · 2 generations on710descendants
- 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 |
|---|---|---|---|---|---|
| −7 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −6 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −5 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −4 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −3 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −2 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −1 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| 0 (this device) | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| +1 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| +2 | K062073 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| +1 | K082342 | Modification to Capstone Spinal System | Medtronic Sofamor Danek | 2008 | — |
| +2 | K082732 | Modification to: Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| +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 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 10 | 0 |
| 2012 | 8 | 0 |
| 2013 | 13 | 0 |
| 2014 | 24 | 0 |
| 2015 | 31 | 0 |
| 2016 | 46 | 0 |
| 2017 | 71 | 0 |
| 2018 | 69 | 0 |
| 2019 | 77 | 0 |
| 2020 | 97 | 0 |
| 2021 | 84 | 1 |
| 2022 | 81 | 0 |
| 2023 | 105 | 0 |
| 2024 | 101 | 0 |
| 2025 | 86 | 0 |
| 2026 | 77 | 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? (2)
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 |
|---|---|---|---|
| * | K041556 | Modification to Verte-Stack Spinal SystemSummary page 2…which demonstrated the VERTE-STACKTM Spinal System to be substantially equivalent to the previously cleared VERTE-STACK TM Spinal System components found in K04 1556 and K040422. 000051… | 2004 |
| * | K040422 | Modification to Verte-StackSummary page 2…trated the VERTE-STACKTM Spinal System to be substantially equivalent to the previously cleared VERTE-STACK TM Spinal System components found in K04 1556 and K040422. 000051… | 2004 |
What descends from it? (999)
See all 9992 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 6 months on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K060719 (Medtronic Sofamor Danek, 2006) has gone furthest, with 992 descendants of its own.
- 4 other devices also cite its predicate K041556.
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 TM 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-STACKTM Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACKTM device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, the Titanium DYNALOKTM CLASSIC Spinal System, the VANTAGE TM Anterior Fixation System, the Titanium TSRH® Spinal System, the Titanium CD HORIZON® Spinal System or the Titanium GDLH® Spinal System. Additionally, the VERTE-STACK TM device is intended to be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043561: 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/K043561
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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