# K033926: Hourglass Vertebral Body Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Jul 7, 2004 after 202 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003155 (2001). 10 ancestors in all.
763 later devices descend from it; 3 cite it directly.
1 of 774 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030736: Verte-Stack Spinal System, Extra Small Sizes, Medtronic Sofamor Danek (2003) Summary page 4.
- K031780: Verte-Stack Spinal System, Medtronic Sofamor Danek (2003) Summary page 4.
- (no number) ZPLATE-II Anterior Fixation System: named in the summary without a submission number

## Most influential descendants
- K120368: Capstone Control Spinal System (2012), 761 descendants of its own
- K121760: Capstone Spinal System (2012), 723 descendants of its own
- K123027: Capstone (R) Spinal System (2013), 709 descendants of its own
- K141896: Coroent System (2014), 480 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K033926
Methodology: https://510kreport.com/methodology