Amber Implants Secures FDA 510(k) Clearance for VCFix® Spinal System: A Next-Generation Solution for Vertebral Compression Fractures

• FDA clearance confirms robust safety and performance of VCFix® Spinal System, a breakthrough treatment for vertebral compression fractures
• US commercial pilot launch planned for early 2026, followed by broader physician availability from summer 2026
• One-year trial data show significant clinical improvements, supporting VCFix® Spinal System as a potential new standard of care

THE HAGUE, The Netherlands, Sept. 17, 2025 /PRNewswire/ -- Amber Implants, an innovative medical technology company developing next-generation implants for spinal injuries, today announced it has received clearance from the US Food and Drug Administration (FDA) for its VCFix® Spinal System. This clearance confirms the device's safety and performance and represents a globally recognized validation of its clinical value, providing immediate access to the world's largest MedTech market.

The VCFix® Spinal System is a vertebral augmentation system designed to treat a broad spectrum of vertebral compression fractures. This minimally invasive solution is used with bone cement and provides strong anterior and posterior column support. It integrates seamlessly into existing surgical workflows, with the potential to improve spinal stabilization, reduce patient risk, and shorten procedure times, compared to current options.

One-year follow-up data from initial clinical trials of the VCFix® Spinal System, announced in June 2025, demonstrated immediate and sustained reduction in pain, improved spinal stability, and faster recovery, underscoring its potential for lasting functional benefits. Amber Implants is also working towards CE marking in the EU, aiming for broad labeling that supports both stand-alone use of VCFix®, and integration with posterior fixation systems.

Dr. Banafsheh Sajadi, Co-Founder and Chief Executive Officer of Amber Implants, 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, and this clearance lays the foundation to initiate our commercial launch activities."

Each year, more than 9 million people worldwide suffer vertebral compression fractures, including around 2 million across North America and Europe. Despite this high prevalence, up to two-thirds of cases remain undiagnosed and undertreated, leaving elderly and frail patients—most often with osteoporosis—at risk of chronic pain, spinal deformity, disability, and loss of independence. Current treatment options are limited: kyphoplasty is minimally invasive but fails to provide posterior support for fractures, while posterior fixation is invasive, restricts motion, and prolongs recovery with higher morbidity. The VCFix® Spinal System addresses these gaps as a minimally invasive solution that uniquely supports both anterior and posterior columns, integrates seamlessly into existing surgical workflows, and delivers greater stability with less patient risk.

Dr. Mohammad Ahmadi, Co-Founder and Chief Technology Officer of Amber Implants, added: "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."

Amber Implants is now a commercial stage company, preparing for its US launch in 2026. Supported by strong worldwide patent protection and a growing product pipeline, the Company is on track to capture a significant share of the global €2 billion+ vertebral compression fracture market by 2029. FDA clearance of the VCFix® Spinal System not only accelerates adoption and revenue growth but also serves as a gateway for entry into additional global markets where FDA approval is recognized.

About Amber Implants
Amber Implants is a commercial-stage medical technology company with operations in the Netherlands and the US. Founded in 2018, the Company develops next-generation implants for spinal injuries with the goal of improving patient outcomes through more natural healing and enhanced spinal stability. Its flagship product, the VCFix® Spinal System, offers a simpler, more efficient, and safer approach for managing a broad range of spinal fractures.

Amber Implants is financed by the Founders and venture capital investors, with participation from angel investors and non-dilutive government funding. In June 2025, the Company reported one-year follow-up data for the VCFix® Spinal System from its first-in-human trial showing significant improvements in key clinical performance outcomes, and the device received FDA 510(k) Clearance from the US Food and Drug Administration (FDA) in September 2025.    

SOURCE Amber Implants