Amber Implants has earned U.S. Food and Drug Administration (FDA) clearance for its VCFix spinal system.

VCFix is a vertebral augmentation system designed to treat a broad array of vertebral compression fractures. The minimally invasive solution is used with bone cement and, according to the company, offers strong anterior and posterior column support.

The company also said it seamlessly integrates into existing surgical workflows and has the potential to improve spinal stabilization, reduce patient risk, and shorten procedure time compared to current options.

Data from initial clinical trials of VCFix revealed in June 2025 showed immediate, sustained pain reduction. The data also demonstrated improved spinal stability and quicker recovery. Amber Implants is working toward CE marking in the EU, aiming for broad labeling to support both standalone use and integration with posterior fixation systems.

“The VCFix Spinal System is a groundbreaking vertebral augmentation solution with the potential to establish a new standard of care in vertebral fracture management, reinforcing Amber Implants’ role as a global innovator in spinal fracture solutions,” said Amber Implants co-founder and CEO Dr. Banafsheh Sajadi. “The U.S., as the world’s largest medtech market, provides an ideal platform for growth with a potential market in excess of €800m, and this clearance lays the foundation to initiate our commercial launch activities.”

The company is preparing for U.S. launch in 2026 and is on track to nab a significant share of the global €2 billion+ vertebral compression fracture market by 2029.

“We will begin our U.S. commercial launch with a pilot program in early 2026, accompanied by the expansion of the EXPAND pivotal trial into the U.S.,” said Dr. Mohammad Ahmadi, co-founder and chief technology officer of Amber Implants. “This will be followed by broader physician availability from later in 2026. At the same time, we continue to pursue EU label expansion for stand-alone use and integration with one level fixation.”