FX Shoulder Solutions, Inc. Achieves EU MDR Certification for Humelock Reversed® Shoulder System

Major Regulatory Milestone Marks the First Step Toward Global Portfolio Harmonization and Continued Expansion of One of Shoulder Arthroplasty's Most Innovative Portfolios

ADDISON, Texas, Nov. 3, 2026 /PRNewswire/ -- FX Shoulder Solutions, Inc., a global innovator exclusively dedicated to shoulder arthroplasty, today announced that its Humelock Reversed® Shoulder System has achieved certification under the European Union Medical Device Regulation (EU MDR 2017/745).

This significant regulatory milestone marks the first step in FX Shoulder Solutions' strategic initiative to harmonize its product portfolio across international markets, establishing a foundation for greater continuity in product availability, updated instrumentation, and expanded implant options.

As FX continues to develop one of the industry's most innovative and rapidly expanding shoulder arthroplasty portfolios, this certification reinforces the company's commitment to combining established clinical performance with next-generation technologies and comprehensive reconstructive solutions.

A Legacy of Clinical Performance

Humelock Reversed® (the legacy device to the FX V135® Humelock) represents an established foundation of FX Shoulder Solutions' reverse shoulder arthroplasty portfolio, supported by post-market clinical follow-up (PMCF) data demonstrating favorable outcomes.

In a PMCF cohort of 138 patients with at least three years of follow-up, Humelock Reversed® (the legacy device to the FX V135® Humelock) demonstrated:

• 0.72% revision rate for instability (1 of 138 patients).
• 1.45% device-related revision rate (2 of 138 patients).
• 2.17% overall revision rate (3 of 138 patients).
• No reported implant migration or subsidence.

These clinical findings reflect the established heritage of the Humelock Reversed® platform and reinforce FX's continued focus on implant stability, clinical outcomes, and long-term performance.

The system's EU MDR certification supports the continued availability of this established technology while laying the groundwork for the broader evolution of FX's international shoulder arthroplasty portfolio.

The certification represents more than regulatory compliance. It is a foundational step in FX Shoulder Solutions' strategy to create greater consistency across international markets while continuing to expand the breadth of its shoulder reconstruction technologies.

Through this initiative, FX intends to progressively align its global portfolio, incorporating revised surgical instrumentation, additional implant options, and continued advancements in its comprehensive shoulder arthroplasty systems, subject to applicable regulatory requirements.

"This achievement is an important milestone in our global strategy and represents the first step toward a more unified FX portfolio across international markets," said Baptiste Martin, CEO of FX Shoulder Solutions. "We have built our reputation on challenging conventional approaches to shoulder arthroplasty through meaningful innovation. As one of the fastest growing and most innovative portfolios in the industry, our focus is not simply on expanding the number of products we offer, but on ensuring that surgeons worldwide have access to comprehensive solutions supported by clinical evidence, surgical flexibility, and efficient instrumentation."

FX Shoulder Solutions has established a differentiated portfolio spanning stemless reconstruction, primary shoulder arthroplasty, complex fractures, and revision procedures.

Building upon its legacy of interlocking humeral stems, intraoperative flexibility, and streamlined instrumentation, FX continues to advance implant technologies and surgical solutions designed to address the evolving demands of shoulder reconstruction.

The EU MDR certification of Humelock Reversed® is an important step in this ongoing evolution, supporting the company's long-term commitment to portfolio continuity, international market alignment, and continued innovation.

Unmatched Innovation. From Stemless to Revision.

About FX Shoulder Solutions

FX Shoulder Solutions, Inc. is a global medical device company exclusively dedicated to shoulder arthroplasty. Headquartered in Addison, Texas, FX offers a comprehensive portfolio of innovative shoulder reconstruction solutions spanning stemless, primary, fracture, and revision arthroplasty.

Through its commitment to clinical outcomes, intraoperative flexibility, and efficient surgical instrumentation, FX continues to advance one of the industry's most innovative shoulder arthroplasty portfolios.

For more information, visit www.fxshouldersolutions.com.

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FX Shoulder Solutions, Inc.
www.fxshouldersolutions.com

SOURCE FX Shoulder Solutions