FDA cleared Easytech Reversed, which FX Shoulder Solutions says is the first stemless reverse shoulder arthroplasty system cleared in the US. The implant uses peripheral fixation that engages proximal humeral bone near the cortical boundaries, rather than a stem running down the humeral shaft. The release does not give a K number.
It shares its humeral anchor base with the Easytech stemless anatomical system, which FX has sold in the US since 2021. The supporting IDE study opened in 2018, enrolled 90 patients at seven sites and finished follow-up in 2023. The system ships in two instrument trays.
Lead investigator Howard W. Harris of Texas Orthopedic Specialists said FX brought the long-awaited stemless reverse platform to the US market. Uma Srikumaran pointed to patients with atypical proximal humeral anatomy and malaligned intramedullary canals. FX Shoulder Solutions works from Addison, Texas, with operations in the US and France, and gave no launch date.
Sharing one anchor base across anatomic and reverse configurations is the quieter commercial result. Hospitals already stocking Easytech trays pick up a second indication without a new inventory conversation.