FX Shoulder Solutions Makes History with FDA Clearance of Easytech Reversed®, the First-and-Only Stemless Reverse Shoulder System in the United States

A groundbreaking, first-of-its-kind advancement marks a new era in reverse shoulder arthroplasty, culminating in eight years of US clinical investigation and regulatory development

ADDISON, Texas, Nov. 5, 2026 /PRNewswire/ -- 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 Reversed^® — 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.

Eight Years in the Making: A Historic Commitment to Innovation

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^®.

Nearly eight years after initiating its US clinical investigation, FX has achieved a milestone that establishes a new chapter in the history of shoulder arthroplasty.

This achievement underscores FX's unwavering commitment to advancing surgical technology, pursuing meaningful innovation, and investing in the clinical evidence necessary to bring differentiated solutions to the US market.

At the heart of Easytech Reversed^® is FX's distinctive peripheral fixation technology, a design philosophy that fundamentally differs from traditional stemmed reverse shoulder arthroplasty.

The Easytech Reversed^® System leverages the same humeral anchor base architecture as the Easytech^® Stemless Anatomical System, available in the United States since 2021. Its innovative design is intended to engage proximal humeral bone near the cortical boundaries, eliminating the need for a conventional diaphyseal stem.

By introducing this fixation concept to reverse shoulder arthroplasty, FX is expanding the possibilities of humeral reconstruction and providing surgeons with a fundamentally different implant option for appropriately selected patients, consistent with the indications of the cleared device.

The system also incorporates FX's commitment to streamlined surgical workflows, utilizing just two instrument trays to support procedural efficiency.

A Defining Moment for FX and the Shoulder Arthroplasty Market

"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, Chief Executive Officer of FX Shoulder Solutions.

"Eight years ago, we committed ourselves to bringing a technology to the US market that challenged the conventional approach to reverse shoulder replacement. We knew this would require significant clinical investment, perseverance, and an unwavering belief in the potential of stemless fixation. Today, that commitment has become a reality."

"Being first is significant. But what makes this achievement truly meaningful is the opportunity to change what is possible in shoulder reconstruction. Easytech Reversed^® represents the kind of groundbreaking innovation that drives our company forward. We are not here to simply follow the evolution of shoulder arthroplasty — we are here to help define its future."

Howard W. Harris, MD, of Texas Orthopedic Specialists, served as one of the lead investigators in the Easytech Reversed^® IDE investigation.

"FX has provided the long-awaited stemless reverse shoulder replacement platform to the US market with the Easytech Reversed^® System. The option to perform stemless reverse replacements will allow orthopedic surgeons to provide less invasive, anatomically adaptable, and efficient surgery for our patients. The ability to use the Easytech^® implant for both stemless anatomic and stemless reverse shoulder replacement is a great complement to the extensive array of stemmed humeral implant options available from FX," said Dr. Harris.

The introduction of Easytech Reversed^® to the US market represents another defining milestone in FX's continued expansion of one of the industry's most differentiated shoulder arthroplasty portfolios.

From stemless anatomical and reverse shoulder reconstruction to complex fractures and revision procedures, FX continues to challenge conventional implant design through advanced fixation concepts, intraoperative flexibility, modularity, and streamlined instrumentation.

"Easytech Reversed^® marks an important milestone in the evolution of reverse shoulder arthroplasty and reflects FX's sustained commitment to meaningful innovation," said Uma Srikumaran, MD, MBA, MPH, of Columbia, Maryland. "Easytech Reversed^® introduces a fundamentally different approach to reverse shoulder reconstruction, offering surgeons a unique fixation option for patients with atypical proximal humeral anatomy or malaligned intramedullary canals, as well as those meeting traditional reverse shoulder arthroplasty indications. Its innovative, unique-to-market peripheral fixation design provides the opportunity to achieve humeral fixation without a conventional intramedullary stem in appropriately selected patients, representing a significant advancement in the options available for shoulder reconstruction."

The revolutionary clearance of Easytech Reversed^® reinforces FX's commitment to bringing meaningful technological advancements to surgeons and patients worldwide while continuing to develop the next generation of shoulder arthroplasty solutions.

The future of shoulder arthroplasty is evolving — and FX is helping lead that evolution.

About FX Shoulder Solutions

FX Shoulder Solutions is a global orthopedic medical device company dedicated exclusively to shoulder arthroplasty. With operations in the United States and France, FX develops innovative implant systems and enabling technologies designed to support surgeons across primary, fracture, and revision shoulder reconstruction.

Guided by its commitment to Unmatched Innovation. From Stemless to Revision, FX continues to advance a comprehensive shoulder arthroplasty portfolio focused on surgical flexibility, procedural efficiency, and clinical outcomes.

For more information, visit www.fxshouldersolutions.com.

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FX Shoulder Solutions, Inc.
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SOURCE FX Shoulder Solutions