FX Shoulder Solutions has received US Food and Drug Administration (FDA) 510(k) clearance for its Easytech Reversed system, which the company describes as the first and only stemless reverse shoulder arthroplasty system cleared in the United States.
The clearance introduces a stemless fixation approach to reverse shoulder replacement in the US market, offering an alternative to conventional systems that rely on a humeral stem.
According to FX, the regulatory milestone follows an extensive clinical investigation that began in 2018 under a US Investigational Device Exemption (IDE). The multicentre study was conducted across seven investigational sites and involved 90 patients. Patient follow-up was completed in 2023, contributing to the clinical evidence supporting the device’s development and regulatory evaluation.
“Today marks a revolutionary and historic achievement, not only for FX Shoulder Solutions, but for the evolution of shoulder arthroplasty in the United States,” said Baptiste Martin, CEO of FX Shoulder Solutions.
At the core of the Easytech Reversed system is FX’s peripheral fixation technology, which differs from traditional stemmed reverse shoulder arthroplasty systems. The implant uses the same humeral anchor base architecture as the company’s Easytech Stemless Anatomical System, which has been available in the US since 2021.
The design is intended to achieve fixation in the proximal humerus near the cortical boundaries, eliminating the need for a conventional diaphyseal stem. This approach provides surgeons with an alternative for humeral reconstruction, subject to the cleared device indications and appropriate patient selection.
The system also incorporates a streamlined surgical instrumentation design, requiring two instrument trays to support procedural efficiency.
Howard W. Harris of Texas Orthopedic Specialists, one of the lead investigators in the IDE study, said the option to perform stemless reverse replacements will allow orthopaedic surgeons to provide “less invasive, anatomically adaptable, and efficient surgery” for patients.
He added that the ability to use the Easytech implant for both anatomic and reverse stemless shoulder replacement complements the company’s existing range of stemmed humeral implants.
FX Shoulder Solutions is a global orthopaedic medical device company focused exclusively on shoulder arthroplasty, with operations in the US and France. Its portfolio includes implant systems and technologies for primary, fracture and revision shoulder reconstruction.
With the US clearance of Easytech Reversed, the company is expanding its stemless shoulder reconstruction portfolio and strengthening its presence in the US orthopaedic medical device market.
