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.
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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.
Amber Implants CEO and co-founder Dr Banafsheh Sajadi said: “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 (approximately $947m), and this clearance lays the foundation to initiate our commercial launch activities.”
Data from a one-year follow-up after initial studies of the system, which were shared in June, indicated that the system offers immediate and long-term pain reduction, spinal stability, and quicker recovery times.
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By GlobalDataFurthermore, Amber Implants is working to obtain CE marking in the European Union (EU) and aims for extensive labelling that will allow for both standalone use of the VCFix system and its integration with posterior fixation systems.
Amber Implants chief technology officer and co-founder Dr Mohammad Ahmadi said: “We will begin our US commercial launch with a pilot programme 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 standalone use and integration with one-level fixation.”
Last year, Amber Implants completed patient enrolment in its first-in-human trial, which assessed the efficacy of the VCFix spinal system in the treatment of vertebral compression fractures.
