Major Regulatory Milestone Marks the First Step Toward Global Portfolio Harmonization and Continued Expansion of One of Shoulder Arthroplasty's Most Innovative Portfolios
FX Shoulder Solutions, Inc. Achieves EU MDR Certification for Humelock Reversed® Shoulder System
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FX Shoulder SolutionsHumelock Reversed Shoulder SystemEU Medical Device Regulation
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.
Media Contact
FX Shoulder Solutions, Inc.
www.fxshouldersolutions.com
SOURCE FX Shoulder Solutions
Author
TH
TJ Halvorson
The De Angelis Group | Orthopedics This Week | MSK Innovations
Why This Matters
Two Perspectives
MBA Lens: Economic and industry impact
FX Shoulder Solutions achieved EU MDR certification for its Humelock Reversed® Shoulder System, a strategic move to harmonize its global portfolio and expand market access. This milestone supports continuity in product availability, updated instrumentation, and broader implant options, reinforcing FX's commitment to innovation and competitive positioning in the shoulder arthroplasty market. It's a foundational step for international market alignment.
- The certification enables broader market access and portfolio consistency across international markets, supporting future product expansions.
- This regulatory achievement strengthens FX's competitive stance by ensuring continued availability of an established product and facilitating global portfolio alignment.
PhD Lens: Clinical and outcomes impact
The Humelock Reversed® Shoulder System, a legacy device to the FX V135® Humelock, secured EU MDR certification, affirming its established clinical performance. Post-market clinical follow-up data from 138 patients over three years showed a 0.72% revision rate for instability, 1.45% device-related revision rate, and 2.17% overall revision rate, with no reported implant migration, underscoring its stability.
- Clinical data demonstrated low revision rates (0.72% for instability, 1.45% device-related, 2.17% overall) and no implant migration in a 138-patient cohort.
- The system represents a foundational reverse shoulder arthroplasty technology, with EU MDR certification supporting its continued availability and future evolution.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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