510(k) · Cleared
ClearedModified 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 Apr 18, 2003 as substantially equivalent to K023570 (Medtronic Sofamor Danek, 2002) and 1 other predicate after a 39-day review. Its family tree reaches back 4 generations to 2001. 1 of the 825 devices in its family, counting itself, has a Class I recall. 816 later devices descend from it.
- Decided
- Apr 18, 2003
- Review
- 39 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K003155 (2001). 8 ancestors in all, the oldest K841189 (1984). 816 later devices descend from it, 3 citing it directly. 1 of the 825 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 3 generations backK012254 VBROsteotech, Inc. · 2001
- 2 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 1 generation backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- This deviceK030735 Modified Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- Descendant · cites it directly · 815 of its ownK041452 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- Descendant · 2 generations on · 796 of its ownK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- Descendant · 3 generations on · 761 of its ownK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · 2 generations on · 726 of its ownK043566 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2005
- Descendant · 4 generations on · 723 of its ownK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
Showing 5 of 816 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 816 · See all- K041452Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004 · cites it directly815descendants
- K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009 · 2 generations on796descendants
- K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 3 generations on761descendants
- K043566Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2005 · 2 generations on726descendants
- K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 4 generations on723descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −3 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −2 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −1 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| 0 (this device) | K030735 | Modified Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| +1 | K041452 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| +2 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| +3 | K120368 | Capstone Control Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +2 | K043566 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2005 | — |
| +4 | K121760 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K023570 | Modification to Verte-Stack Spinal SystemSummary page 2…cumentation was provided which demonstrated the VERTE-STACKTMSpinal System to be substantially equivalent to the previously cleared VERTE-STACKTMSpinal System (K023570, SE 11/19/02 and K021791, SE 08/26/02). DEPARTMENT OF HEALTH 8r HUMAN SERVICES… | 2002 |
| * | K021791 | Verte-Stack Spinal SystemSummary page 2…which demonstrated the VERTE-STACKTMSpinal System to be substantially equivalent to the previously cleared VERTE-STACKTMSpinal System (K023570, SE 11/19/02 and K021791, SE 08/26/02). DEPARTMENT OF HEALTH 8r HUMAN SERVICES Public Health Se… | 2002 |
What descends from it? (816)
See all 8163 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 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K041452 (Medtronic Sofamor Danek, 2004) has gone furthest, with 815 descendants of its own.
- 7 other devices also cite its predicate K023570.
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 tht: thoracolumbar spine (Tl-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (Le., fracture). The VERTE-STACKTMSpinal System is to be used with supplemental fixation. Specifically, the VERTE-STACKTM device is to be used with the Medtronic Sofamor Danek ZPLATE I1 Anterior Fixation System, Titanium DYNALOKTMCLASSIC Spinal System, the VANTAGETMAnterior Fixation System, Titanium TSRHB Spinal System, Titanium CD HORIZONB Spinal System, the Titanium GDLHB Spinal System, or their successors. Additionally, the VERTE-STACKW device is intended to be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030735 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030735: Modified Verte-Stack 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/K030735
Report an extraction error
Are you the manufacturer?
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