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, 17 September 2025 – 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.
