# K024049: Verte-Span Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Feb 26, 2003 after 79 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: 1 generation back to K010930 (2001). 1 ancestor in all.
73 later devices descend from it; 3 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010930: Lift VB Spinal System, Medtronic Sofamor Danek, Inc. (2001)

## Most influential descendants
- K071033: T2 XVBR Spinal System (2007), 50 descendants of its own
- K110864: Biospine VBR System (2011), 49 descendants of its own
- K100976: T2 XVBR 1.5 Spinal System (2010), 49 descendants of its own
- K133802: Ais Modulift VBR System (2014), 48 descendants of its own
- K173125: T2 STRATOSPHERE™ Expandable Corpectomy System (2017), 47 descendants of its own

## Indications for use
The VERTE-SPAN Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (Tl-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-SPAN Spinal System is to be used with supplemental fixation. Specifically, the VERTE-SPAN device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, Titanium DYNALOK CLASSIC Spinal System, LAURAIN DEWALD Anterior Fixation System, Titanium TSRHB Spinal System, Titanium CD HORIZON Spinal System or the Titanium GDLH Spinal System. Additionally, the VERTE-SPAN device is intended to be used with bone graft.

Source page: https://510kreport.com/device/K024049
Methodology: https://510kreport.com/methodology