FX Shoulder Wins FDA Nod for FX V135 Easytech Shoulder System

FX Shoulder Solutions has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for the FX V135 Easytech shoulder system, its next generation of stemless shoulder arthroplasty implants that offer surgeons with an anatomic stemless versus a modular stemmed-reverse option.

The design lets surgeons begin with a stemless approach, and when clinically appropriate, transition intraoperatively to a short stem solution without changing or adding another system. The entire workflow is supported by one humeral tray.

FX V153 Easytech is available in the anatomic configuration with an optional short stem conversion and in the reverse configuration with the short stem option. Both configurations are at 135° and the reverse configuration allows for a 145° option.

The system’s anchor base sizes are 32 mm, 36 mm, 38 mm, 40 mm, 44 mm, and the humeral stem adaption is 8 mm in diameter. It’s compatible with previously cleared humeral head and glenoid options for the anatomic and glenoid baseplate and glenosphere options for the reverse.

FX V135 Easytech builds on the FX V135 platform (Mini, Humelock, Long) with enhancements designed improve precision like centered humeral cup tapers, introduction of a +1 mm humeral cup option, and more ability to fine-tune soft tissue tensioning mid-procedure.

“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.”