510(k) · Cleared
ClearedHourglass Vertebral Body Spacer
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 7, 2004 as substantially equivalent to K030736 (Medtronic Sofamor Danek, 2003) and 1 other predicate after a 202-day review. Its family tree reaches back 5 generations to 2001. 1 of the 774 devices in its family, counting itself, has a Class I recall. 763 later devices descend from it.
- Decided
- Jul 7, 2004
- Review
- 202 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K003155 (2001). 10 ancestors in all, the oldest K841189 (1984). 763 later devices descend from it, 3 citing it directly. 1 of the 774 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 4 generations backK012254 VBROsteotech, Inc. · 2001
- 3 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 2 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 1 generation backK030736 Verte-Stack Spinal System, Extra Small SizesMedtronic Sofamor Danek · 2003
- This deviceK033926 Hourglass Vertebral Body SpacerMedtronic Sofamor Danek · 2004
- Descendant · cites it directly · 761 of its ownK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · 2 generations on · 723 of its ownK121760 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · 2 generations on · 709 of its ownK123027 Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- Descendant · 3 generations on · 480 of its ownK141896 Coroent SystemNu Vasive, Incorporated · 2014
- Descendant · 4 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
Showing 5 of 763 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 763 · See all- K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · cites it directly761descendants
- K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 2 generations on723descendants
- K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc. · 2013 · 2 generations on709descendants
- K141896Coroent SystemNu Vasive, Incorporated · 2014 · 3 generations on480descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 4 generations on479descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −4 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −3 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −2 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −1 | K030736 | Verte-Stack Spinal System, Extra Small Sizes | Medtronic Sofamor Danek | 2003 | — |
| 0 (this device) | K033926 | Hourglass Vertebral Body Spacer | Medtronic Sofamor Danek | 2004 | — |
| +1 | K120368 | Capstone Control Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +2 | K121760 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +2 | K123027 | Capstone (R) Spinal System | Medtronic Sofamor Danek, Inc. | 2013 | — |
| +3 | K141896 | Coroent System | Nu Vasive, Incorporated | 2014 | — |
| +4 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 12 | 0 |
| 2015 | 13 | 0 |
| 2016 | 29 | 0 |
| 2017 | 44 | 0 |
| 2018 | 54 | 0 |
| 2019 | 64 | 0 |
| 2020 | 78 | 0 |
| 2021 | 67 | 1 |
| 2022 | 71 | 0 |
| 2023 | 88 | 0 |
| 2024 | 94 | 0 |
| 2025 | 75 | 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? (3)
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 |
|---|---|---|---|
| * | K030736 | Verte-Stack Spinal System, Extra Small SizesSummary page 4…TM be substantially equivalent to the previously cleared VERTE-STACK Spinal System (K030736 and K031780) and the ZPLATE-11® Anterior Fixation System in terms of its size, indications for use and use with su… | 2003 |
| * | K031780 | Verte-Stack Spinal SystemSummary page 4…TM be substantially equivalent to the previously cleared VERTE-STACK Spinal System (K030736 and K031780) and the ZPLATE-11® Anterior Fixation System in terms of its size, indications for use and use with supplemental fixation.… | 2003 |
| * | — | ZPLATE-II Anterior Fixation System Named without a submission number |
What descends from it? (763)
See all 7633 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 · 6 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 9 months on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K120368 (Medtronic Sofamor Danek USA, Inc., 2012) has gone furthest, with 761 descendants of its own.
- 8 other devices also cite its predicate K030736.
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 HOURGLASS™ Vertebral Body Spacer is intended to be used in partial corpectomy procedures to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of tumor or trauma (i.e., fracture). The HOURGLASS™ device is to be used with supplemental fixation. Specifically, the HOURGLASS™…
Read the full statement (120 words)
The HOURGLASS™ Vertebral Body Spacer is intended to be used in partial corpectomy procedures to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of tumor or trauma (i.e., fracture). The HOURGLASS™ device is to be used with supplemental fixation. Specifically, the HOURGLASS™ device is to be used with the Medtronic Sofamor Danek ZPLATE-II® Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, and/or the GDLH® Spinal System, or their successors. Additionally, the HOURGLASS™ device is intended to be used with bone graft.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K033926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033926: Hourglass Vertebral Body Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033926
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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