# K023570: Modification to Verte-Stack Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Nov 19, 2002 after 26 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: 3 generations back to K003155 (2001). 7 ancestors in all.
1,383 later devices descend from it; 8 cite it directly.
2 of 1,391 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021791: Verte-Stack Spinal System, Medtronic Sofamor Danek (2002)

## Most influential descendants
- K031780: Verte-Stack Spinal System (2003), 1,326 descendants of its own
- K030601: Verte-Stack Spinal System (2003), 1,151 descendants of its own
- K040536: Modification to Verte-Stack Spinal System (2004), 1,150 descendants of its own
- K030736: Verte-Stack Spinal System, Extra Small Sizes (2003), 1,101 descendants of its own
- K041556: Modification to Verte-Stack Spinal System (2004), 1,002 descendants of its own

## Indications for use
The VERTE-STACKTMSpinal 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-STACKTMSpinal System is to be used with supplemental fixation. Specifically, the VERTE-STACKTMdevice is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, Titanium DYNALOKTMCLASSIC Spinal System, Laurain DeWald Anterior Fixation System, Titanium TSRHB Spinal System Titanium CD HORIZONB Spinal System, the Titanium GDLHB Spinal System, or their successors Additionally, the VERTE-STACKTMdevice is intended to be used with bone graft.

Source page: https://510kreport.com/device/K023570
Methodology: https://510kreport.com/methodology