# K052261: Modification to: Verte-Stack Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Oct 7, 2005 after 49 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: 6 generations back to K003155 (2001). 10 ancestors in all.
839 later devices descend from it; 1 cites it directly.
1 of 850 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040536: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2004) Summary page 2.
- K030601: Verte-Stack Spinal System, Medtronic Sofamor Danek (2003) Summary page 2.
- K021791: Verte-Stack Spinal System, Medtronic Sofamor Danek (2002) Summary page 2.

## Most influential descendants
- K094025: Crescent Spinal System (2010), 838 descendants of its own
- K110543: Crescent (R) Spinal System Titanium (2011), 808 descendants of its own
- 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

## Indications for use
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, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK® device is intended to be used with bone graft.

Source page: https://510kreport.com/device/K052261
Methodology: https://510kreport.com/methodology