# K051000: Fortitude Vue Vertebral Body Replacement Device

- Pathway: 510(k) (Special)
- Applicant: Spinal Concepts, Inc.
- Decided: May 19, 2005 after 29 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 K010530 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031914: Spinal Concepts, Inc. Cadence and Fortitude, Spinal Concepts, Inc. (2003) Summary page 1.

## Indications for use
Fortitude Vue is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). Fortitude Vue is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Fortitude Vue is intended to be used with bone graft.

Source page: https://510kreport.com/device/K051000
Methodology: https://510kreport.com/methodology