# K042714: Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4

- Pathway: 510(k) (Traditional)
- Applicant: Spine Next America Corporation
- Decided: Dec 29, 2004 after 96 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). 18 ancestors in all.
838 later devices descend from it; 3 cite it directly.
1 of 857 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011037: Vertebral Spacer, Synthes (Usa) (2002)
- K042268: Ebi Cas Spine Spacer System, Ebi, L.P. (2004). Cleared while this submission was under review Summary page 1.
- K031780: Verte-Stack Spinal System, Medtronic Sofamor Danek (2003) Summary page 1.

## Most influential descendants
- K051246: Construx Mini Peek VBR System (2005), 834 descendants of its own
- K060350: Construx PL/TL Peek Partial VBR System (2006), 754 descendants of its own
- K081849: Blackstone Pillar SA Partial Vertebral Body Replacement Device (2008), 753 descendants of its own
- K100043: Coroent XLR Standalone System (2010), 744 descendants of its own
- K123045: Brigade Standalone System (2013), 696 descendants of its own

## Indications for use
FIDJI types 1, 2, 3, and 4 are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (TI-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. These devices are intended to be used with bone graft and supplemental fixation, such as the Spinal Concepts, Inc. InCompass System.

Source page: https://510kreport.com/device/K042714
Methodology: https://510kreport.com/methodology