FDA clears Amber Implants’ vertebral augmentation system

The company is working to obtain CE marking of the system in the European Union.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Amber Implants’ VCFix Spinal System, intended for treating a wide array of vertebral compression fractures.

The minimally invasive system employs bone cement to offer support to both the anterior and posterior spinal columns, and it can be smoothly incorporated into existing surgical workflows.

Additionally, it is designed to enhance spinal stabilisation, potentially shorten the duration of medical procedures, and decrease the risks for patients when compared to the treatment alternatives currently available.

Sign up for Blog Updates