# K073505: Modification to Valeo VBR

- Pathway: 510(k) (Special)
- Applicant: Amedica Corp.
- Decided: Jan 9, 2008 after 27 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: 2 generations back to K051525 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073125: Valeo VBR, Amedica Corp. (2007) Summary page 2.
- K051525: Arx Spinal System, Amedica Corp. (2006) Summary page 2.

## 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 (T1 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/K073505
Methodology: https://510kreport.com/methodology