FX Shoulder Solutions, Inc. Receives FDA 510(k) Clearance for FX V135® Easytech Shoulder System

The Next Generation of Stemless Has Arrived

ADDISON, Texas, May 5, 2026 /PRNewswire/ -- FX Shoulder Solutions, Inc. has received FDA 510(k) clearance for the FX V135® Easytech Shoulder System, the next generation of stemless shoulder arthroplasty implants that provides surgeons with an anatomic stemless versus a modular stemmed-reverse option.  This design enables surgeons to begin with a stemless approach and, when clinically appropriate, transition intraoperatively to a short stem solution without changing or adding another system.

This entire workflow is supported through one humeral tray.  FX reinforces its long-standing commitment to minimal instrumentation since 2011 with its 2 trays and purposeful instrumentation without compromising implant options or sizing.  The newly approved system is unique-to-market and the only one in the USA with a modular construct that integrates a stemless anchor base with a removable (anatomic) stem adaptation into a single humeral platform.

The FX V135® Easytech is available in the Anatomic Configuration as a Stemless with optional short stem conversion; in the Reverse Configuration with the short stem option.  Both the anatomic and reverse configurations are at 135° while the reverse configuration allows for a 145° option.  The anchor base sizes are 32mm, 36mm, 38mm, 40mm, 44mm and the humeral stem adaptation is 8mm in diameter.  The system is compatible with previously cleared humeral head and glenoid options for the anatomic and glenoid baseplate and glenosphere options for the reverse. The world's only stemless with peripheral fixation and a movable stem for instability purpose.

The FX V135® Easytech builds upon the FX V135® platform (Mini, Humelock®, Long) with key enhancements designed to improve precision including: Centered humeral cup tapers, the introduction of a +1mm humeral cup option (previously +3mm minimum), greater ability to fine-tune soft tissue tensioning intraoperatively.

"This clearance represents a significant step forward in our mission to simplify complexity without limiting surgeon choices," said Baptiste Martin, CEO of FX Shoulder Solutions. "FX V135® Easytech is designed to give surgeons the flexibility to adapt in real time—moving from stemless to stemmed fixation within a single system—while maintaining the efficiency of a single-tray solution which allows  an easy adaptation to ASC market. This is a continuation of what has defined FX since the beginning: purposeful innovation that respects both surgical workflow and patient-specific needs. It is the continuation of our new generation FX V135® portfolio."

FX V135® Easytech further strengthens the FX Shoulder Solutions portfolio, delivering one of the world's fastest growing and most innovative shoulder arthroplasty platforms spanning stemless, primary, fracture, and revision solutions—all built on a foundation of efficiency and intraoperative adaptability.

FX Shoulder Solutions continues to innovate based on surgeon feedback, with an exclusive focus on shoulder arthroplasty and a commitment to advancing surgical outcomes through thoughtful design.

FX Shoulder Solutions, Inc. is based in Addison, Texas. For additional information, please visit www.fxshouldersolutions.com.

For More Information Contact:
FX Shoulder Solutions, Inc.
Phone 1-800-280-0775
Fax 1-800-429-8965
[email protected]

SOURCE FX Shoulder Solutions