FX Shoulder Solutions Receives FDA Clearance for Stemless Reverse Shoulder System
US regulators have approved the Easytech Reversed system, the first stemless reverse shoulder implant available for clinical use in the United States.
FX Shoulder Solutions has secured FDA 510(k) clearance for its Easytech Reversed implant, a device designed for reverse shoulder arthroplasty. The approval follows an eight-year regulatory and clinical development cycle for the device.
Unlike traditional reverse shoulder systems that require a stem to be inserted into the humerus, the Easytech Reversed design eliminates this component. This configuration is intended to preserve humeral bone stock during surgical procedures. By removing the need for an intramedullary stem, the manufacturer aims to simplify the surgical approach and reduce procedural complexity.
The adoption of stemless technology represents a shift in orthopedic surgical practices, where preservation of bone anatomy has become an increasing priority. The company plans to initiate a phased commercial rollout of the device across the United States following this regulatory milestone.