510(k) · Cleared
ClearedVerte-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 Jul 30, 2003 as substantially equivalent to K023570 (Medtronic Sofamor Danek, 2002) and 1 other predicate after a 50-day review. Its family tree reaches back 4 generations to 2001. 2 of the 1,335 devices in its family, counting itself, have a Class I recall. 1,326 later devices descend from it.
- Decided
- Jul 30, 2003
- Review
- 50 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). 1,326 later devices descend from it, 11 citing it directly. 2 of the 1,335 devices in this family, counting this one, have 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 deviceK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- Descendant · cites it directly · 1,002 of its ownK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- Descendant · cites it directly · 1,002 of its ownK040422 Modification to Verte-StackMedtronic Sofamor Danek · 2004
- Descendant · 2 generations on · 999 of its ownK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- Descendant · 2 generations on · 992 of its ownK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- Descendant · cites it directly · 895 of its ownK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
Showing 5 of 1,326 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 1,326 · See all- K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004 · cites it directly1,002descendants
- K040422Modification to Verte-StackMedtronic Sofamor Danek · 2004 · cites it directly1,002descendants
- K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004 · 2 generations on999descendants
- K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006 · 2 generations on992descendants
- K040731Stryker Spine Vertebral SpacerStryker Spine · 2004 · cites it directly895descendants
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) | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| +1 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| +1 | K040422 | Modification to Verte-Stack | Medtronic Sofamor Danek | 2004 | — |
| +2 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| +2 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| +1 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 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 |
|---|---|---|
| 2004 | 7 | 0 |
| 2005 | 6 | 1 |
| 2006 | 11 | 0 |
| 2007 | 6 | 0 |
| 2008 | 8 | 0 |
| 2009 | 5 | 0 |
| 2010 | 8 | 0 |
| 2011 | 20 | 0 |
| 2012 | 24 | 0 |
| 2013 | 25 | 0 |
| 2014 | 59 | 0 |
| 2015 | 55 | 0 |
| 2016 | 81 | 0 |
| 2017 | 115 | 0 |
| 2018 | 100 | 0 |
| 2019 | 108 | 0 |
| 2020 | 110 | 0 |
| 2021 | 93 | 1 |
| 2022 | 92 | 0 |
| 2023 | 113 | 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? (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…strated 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 &HUMAN SERVICES… | 2002 |
| * | K021791 | Verte-Stack Spinal SystemSummary page 2…Spinal 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 &HUMAN SERVICES Public Health Sw… | 2002 |
What descends from it? (1,326)
See all 1,32611 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041556 | Modification to Verte-Stack Spinal System | 2004 | 1,002 |
| K040422 | Modification to Verte-Stack | 2004 | 1,002 |
| K040731 | Stryker Spine Vertebral Spacer | 2004 | 895 |
| K042571 | Stryker Spine Avs TL Peek Spacer | 2005 | 894 |
| K050624 | Stryker Spine Avs PL Peek Spacer | 2005 | 892 |
| K042714 | Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4 | 2004 | 838 |
| K033926 | Hourglass Vertebral Body Spacer | 2004 | 763 |
| K110562 | Telamon Peek Spinal System | 2011 | 306 |
| 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 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, K041556 (Medtronic Sofamor Danek, 2004) has gone furthest, with 1,002 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-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, Titanium DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, Titanium TSRHB Spinal System, Titanium CD HORIZON® Spinal System, the Titanium 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/K031780 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031780: 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/K031780
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