Amber Implants received FDA 510(k) clearance for its VCFix Spinal System.
The Netherlands-based company designed VCFix to treat vertebral compression fractures. The system is a minimally invasive vertebral augmentation device used with bone cement. It provides support to both the anterior and posterior spinal columns and is intended to improve stabilization while reducing patient risk and shortening procedure times.
Related: FDA grants approval for Womed Leaf for women with Asherman Syndrome
One-year follow-up data from initial clinical trials, announced in June, showed sustained pain reduction, improved stability and faster recovery. The company said it is also pursuing CE mark in the European Union.
“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. The US, 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,” CEO and cofounder Banafsheh Sajadi said in a news release.
The company said vertebral compression fractures affect more than 9 million people worldwide each year, including about 2 million across North America and Europe. Current options such as kyphoplasty and posterior fixation leave gaps in care. Amber Implants said VCFix is designed to address these gaps by offering support to both columns of the spine through a minimally invasive approach.
“We will begin our US commercial launch with a pilot program in early 2026, accompanied by the expansion of the EXPAND pivotal trial into the US. 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,” Cofounder and Chief Technology Officer Mohammad Ahmadi said.
