# K030735: Modified Verte-Stack Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Apr 18, 2003 after 39 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: 4 generations back to K003155 (2001). 8 ancestors in all.
816 later devices descend from it; 3 cite it directly.
1 of 825 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023570: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2002) Summary page 2.
- K021791: Verte-Stack Spinal System, Medtronic Sofamor Danek (2002) Summary page 2.

## Most influential descendants
- K041452: Modification to Verte-Stack Spinal System (2004), 815 descendants of its own
- K090353: Perimeter Interbody Fusion Device (2009), 796 descendants of its own
- K120368: Capstone Control Spinal System (2012), 761 descendants of its own
- K043566: Modification to Verte-Stack Spinal System (2005), 726 descendants of its own
- K121760: Capstone Spinal System (2012), 723 descendants of its own

## Indications for use
The VERTE-STACKTMSpinal System is a vertebral body replacement device intended for use in tht: thoracolumbar spine (Tl-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (Le., fracture). The VERTE-STACKTMSpinal 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 DYNALOKTMCLASSIC Spinal System, the VANTAGETMAnterior Fixation System, Titanium TSRHB Spinal System, Titanium CD HORIZONB Spinal System, the Titanium GDLHB Spinal System, or their successors. Additionally, the VERTE-STACKW device is intended to be used with bone graft.

Source page: https://510kreport.com/device/K030735
Methodology: https://510kreport.com/methodology