# K073125: Valeo VBR

- Pathway: 510(k) (Special)
- Applicant: Amedica Corp.
- Decided: Dec 5, 2007 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: 1 generation back to K051525 (2006). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051525: Arx Spinal System, Amedica Corp. (2006) Summary page 2.

## Most influential descendants
- K073505: Modification to Valeo VBR (2008), 0 descendants of its own

## Indications for use
The ValeoTM VBR is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (Ti to L5) to replace or restore height a collapsed, damaged, diseased, or unstable vertebral body or portion thereof, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body. The ValeoTM VBR 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. The ValeoTM VBR is always to be used with supplemental internal spinal fixation. Additionally, the ValeoTM VBR may be used with bone graft.

Source page: https://510kreport.com/device/K073125
Methodology: https://510kreport.com/methodology