# K042713: Fidji-Vertebral Body Replacement Type 5

- Pathway: 510(k) (Traditional)
- Applicant: Spine Next America Corporation
- Decided: Dec 29, 2004 after 90 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: 5 generations back to K003155 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011037: Vertebral Spacer, Synthes (Usa) (2002) Summary page 1.
- K031780: Verte-Stack Spinal System, Medtronic Sofamor Danek (2003) Summary page 1.

## Indications for use
FIDJI type 5 is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T1-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). The device 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. This device is intended to be used with bone graft and supplemental fixation, such as the Spinal Concepts, Inc. InCompass System. Additionally, FIDJI type 5 is intended to be used in a paired configuration.

Source page: https://510kreport.com/device/K042713
Methodology: https://510kreport.com/methodology