Addison, Texas – November 06, 2026 -- FX Shoulder Solutions has received FDA 510(k) clearance for Easytech Reversed, which the company describes as the first and only stemless reverse shoulder arthroplasty system cleared in the United States. The clearance follows nearly eight years of US clinical investigation.
Seven-site IDE study enrolled 90 patients
FX started the US Investigational Device Exemption (IDE) study in 2018. The multicenter investigation ran across seven sites and covered 90 patients. Follow-up was completed in 2023 and supports the regulatory submission, according to the company. FX also cites more than a decade of international clinical experience with its Easytech technology.
Peripheral fixation replaces the conventional humeral stem
Easytech Reversed uses the same humeral anchor base architecture as the Easytech Stemless Anatomical System, which has been available in the US since 2021. The design is intended to engage proximal humeral bone near the cortical boundaries, which removes the need for a conventional diaphyseal stem. The system requires two instrument trays.
Uma Srikumaran, MD, MBA, MPH, of Columbia, Maryland, said the design gives surgeons a fixation option for patients with atypical proximal humeral anatomy or malaligned intramedullary canals, as well as for patients who meet traditional reverse shoulder arthroplasty indications.
Surgeons gain one implant platform for anatomic and reverse procedures
Howard W. Harris, MD, of Texas Orthopedic Specialists and a lead investigator in the IDE study, said the option allows for "less invasive, anatomically adaptable, and efficient surgery." He added that surgeons can now use the Easytech implant for both stemless anatomic and stemless reverse replacement. The platform sits alongside FX's range of stemmed humeral implants.
Baptiste Martin, FX's Chief Executive Officer, said the company committed eight years ago to bringing the technology to the US market. FX's portfolio now covers stemless anatomical and reverse reconstruction, complex fractures and revision procedures.