FDA Clears Vertebral Body Replacement Device

Food and Drug Administration (FDA) for use in the thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture).

The VBR device is manufactured by Ulrich GmbH & Co. (Ulm, Germany). The company believes this is the first time the FDA has specifically cleared any single device for these indications. The system is unique because of its adjustable length feature and its ability to restore biomechanical integrity to the injured spinal column and correct angular deformity without additional external distractors or spreaders. VBR is distributed by Ulrich in all countries except the United States and Canada, where it is distributed by Osteotech (Eatontown, NJ, USA).