Amber Implants Reports the US FDA’s 510(k) Clearance of VCFix Spinal System for Treating Vertebral Compression Fractures
Shots:
- The US FDA has granted 510(k) clearance to VCFix Spinal System for thetreatment of vertebral compression fractures
- The company plans to launch a US pilot program in early 2026, expand physician access later that year, extend the EXPAND trial into the US, & pursue EU label expansion for stand-alone use & one-level fixation integration
- VCFix Spinal System is a minimally invasive vertebral augmentation solution using bone cement to support anterior & posterior columns, enhance stabilization, reduce patient risk, & shorten procedure times for vertebral compression fractures, with trial results reported in Jun 2025
Ref: PRNewswire | Image: Amber Impants| Press Release
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