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 Aug 26, 2002 as substantially equivalent to K010930 (Medtronic Sofamor Danek, Inc., 2001) and 4 other predicates after an 87-day review. Its family tree reaches back 2 generations to 2001. 2 of the 2,054 devices in its family, counting itself, have a Class I recall. 2,047 later devices descend from it.
- Decided
- Aug 26, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K003155 (2001). 6 ancestors in all, the oldest K841189 (1984). 2,047 later devices descend from it, 12 citing it directly. 2 of the 2,054 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 1 generation backK012254 VBROsteotech, Inc. · 2001
- This deviceK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- Descendant · cites it directly · 1,383 of its ownK023570 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 · 1,218 of its ownK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- Descendant · 2 generations on · 1,214 of its ownK043479 MC+ Partial VBRLdr Spine USA · 2005
- Descendant · cites it directly · 1,151 of its ownK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
Showing 5 of 2,047 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 2,047 · See all- K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002 · cites it directly1,383descendants
- K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003 · cites it directly1,326descendants
- K033109Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004 · cites it directly1,218descendants
- K043479MC+ Partial VBRLdr Spine USA · 2005 · 2 generations on1,214descendants
- K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003 · cites it directly1,151descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −1 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| 0 (this device) | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| +1 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| +1 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| +1 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| +2 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| +1 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 12 | 0 |
| 2005 | 17 | 1 |
| 2006 | 19 | 0 |
| 2007 | 9 | 0 |
| 2008 | 16 | 0 |
| 2009 | 18 | 0 |
| 2010 | 17 | 0 |
| 2011 | 44 | 0 |
| 2012 | 69 | 0 |
| 2013 | 89 | 0 |
| 2014 | 116 | 0 |
| 2015 | 115 | 0 |
| 2016 | 129 | 0 |
| 2017 | 166 | 0 |
| 2018 | 152 | 0 |
| 2019 | 144 | 0 |
| 2020 | 145 | 0 |
| 2021 | 127 | 1 |
| 2022 | 125 | 0 |
| 2023 | 160 | 0 |
| 2024 | 133 | 0 |
| 2025 | 116 | 0 |
| 2026 | 104 | 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? (5)
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 |
|---|---|---|---|
| * | K010930 | Lift VB Spinal System | 2001 |
| * | K001340 | Stackable Cage System | 2000 |
| * | K841189 | Oec/Rezaian Spinal FixatorSummary page 1…ally equivalent to the previously cleared VERTE-SPANTMSpinal System (KO 10930), the DePuy AcroMed Stackable Cage System (KO01340) the OECiRezaian Spinal Fixator (K84 1189), the Osteotech Vertebral Body Replacement device (K012254), and the PYRAMESHB-C Implant System (KO1 1406) in ter… | 1984 |
| * | K012254 | VBRSummary page 1…(KO 10930), the DePuy AcroMed Stackable Cage System (KO01340) the OECiRezaian Spinal Fixator (K84 1189), the Osteotech Vertebral Body Replacement device (K012254), and the PYRAMESHB-C Implant System (KO1 1406) in terms of its size, indications for use and use with supplemental fixat… | 2001 |
| * | K011406 | Spinal Mesh System | 2001 |
What descends from it? (2,047)
See all 2,04712 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023570 | Modification to Verte-Stack Spinal System | 2002 | 1,383 |
| K031780 | Verte-Stack Spinal System | 2003 | 1,326 |
| K033109 | Ellys and Aurys Vertebral Body Replacements | 2004 | 1,218 |
| K030601 | Verte-Stack Spinal System | 2003 | 1,151 |
| K030736 | Verte-Stack Spinal System, Extra Small Sizes | 2003 | 1,101 |
| K050809 | CD Horizon Spinal System | 2005 | 870 |
| K052261 | Modification to: Verte-Stack Spinal System | 2005 | 839 |
| K030735 | Modified Verte-Stack Spinal System | 2003 | 816 |
| K041452 | Modification to Verte-Stack Spinal System | 2004 | 815 |
| K042201 | Novel VBR Spinal System | 2004 | 796 |
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 10 months on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K023570 (Medtronic Sofamor Danek, 2002) has gone furthest, with 1,383 descendants of its own.
- 5 other devices also cite its predicate K010930.
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-STACKTM Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (Tl-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 I1 Anterior Fixation System, Titanium DYNALOKTM CLASSIC Spinal…
Read the full statement (102 words)
The VERTE-STACKTM Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (Tl-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 I1 Anterior Fixation System, Titanium DYNALOKTM CLASSIC Spinal System, Laurain DeWald Anterior Fixation System, Titanium TSRHB Spinal System, Titanium CD HORIZON0 Spinal System, the Titanium GDLHB Spinal System, or their successors. Additionally, the VERTE-STACKTM device is intended to be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021791: 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/K021791
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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