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

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.

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