Amber Implants' VCFix spinal system for treating vertebral fractures received a breakthrough device designation from the FDA, according to an Oct. 5 news release.
VCFix is the first vertebral fracture system that doesn't rely on bone cement. Its 3D-printed structure stimulates bone ingrowth and provides stability of loads in the spine, the company said.
A breakthrough designation is granted to technologies that have the potential to provide more effective treatments for certain conditions. It gives companies direct communication with the FDA as well as priority review.