FX Shoulder Solutions, Inc. (FX), a global innovator dedicated exclusively to shoulder arthroplasty, announces a historic and revolutionary breakthrough in shoulder replacement technology with the FDA 510(k) clearance of Easytech Reverse, the first and only FDA-cleared stemless reverse shoulder arthroplasty system in the United States and a game-changer in how surgeons can care for their patients.

This landmark achievement introduces an entirely new category of reverse shoulder replacement technology to the US market, challenging traditional approaches to humeral fixation and potentially transforming the surgical options available to orthopedic surgeons and their patients.

With more than a decade of international clinical experience with Easytech technology, FX brings an established stemless fixation philosophy to the world's largest shoulder arthroplasty market. The US introduction of Easytech Reversed represents not merely another implant option, but a potentially game-changing advancement in the evolution of reverse shoulder reconstruction.

The FDA clearance represents the culmination of an extraordinary journey that began with the initiation of the Easytech Reversed® US Investigational Device Exemption (IDE) clinical investigation in 2018.

Conducted across seven investigational sites and involving 90 patients, the multicenter investigation required years of clinical evaluation, surgeon collaboration, and sustained investment in the development of a technology unlike conventional stemmed reverse shoulder systems. Study follow-up was completed in 2023, contributing to the clinical evidence supporting the development, regulatory evaluation, and eventual 510(k) clearance of Easytech Reversed.