Device Dossier

Ascend NanoTec VBR System - Prosthesis, internal, spine, vertebral body

Device Dossier for Ascend NanoTec VBR System - Prosthesis, internal, spine, vertebral body (Prosthesis, internal, spine, vertebral body, Class IIb,…

Intended purpose

The Ascend VBR System with advanced NanoTec surface treatment is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders. The Ascend NanoTec VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion. The Ascend NanoTec VBR System is intended to be used with supplemental spinal fixation systems for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend NanoTec VBR System is optional.

TGA Public Summary