FX Solutions Completes Easytech Reversed Stemless IDE Enrollment in U.S.

After more than three years, FX has completed enrollment for its Investigational Device Exemption (IDE) study of the Easytech Reversed Stemless system for reverse total shoulder arthroplasty. The study began in December 2018 and consisted of 90 subjects in seven sites. 

“It has been a real pleasure over the last couple of years to participate in this IDE to offer patients a novel solution and to see very favorable outcomes for my patients. Stemless shoulder replacement is here to stay, and it was great being part of the trailblazing group to bring it to the U.S.,” said Michael Bradley, M.D., of Ortho Rhode Island in Wakefield, R.I.

The Easytech Reversed Stemless features peripheral fixation of the humeral component that is designed to be more bone sparing as compared to the traditional stemmed devices and its unique-to-market design for improved fixation to withstand the forces of reverse total shoulder arthroplasty. The Easytech Reversed anchor base is designed to fit peripherally just inside the cortical bone with optimal bone quality for fixation. It is the first and only stemless on the market with peripheral fixation which has been in use in the European market since 2015, according to the company. 
 
“This is not only a major milestone for FX, but for the next generation of stemless shoulder arthroplasty and the way we think about reverse total shoulder arthroplasty. As a small company, we are excited and humbled to lead the way and be the first to complete this historic study that may bring a novel device to the U.S. market which has already seen over 2000 implanted in Europe since 2015,” said Baptiste Martin, CEO of FX Shoulder USA. 
 
“The Easytech Reversed is a unique stemless solution for reverse TSA to provide patients with an anatomically centered humeral articulating component that is bone sparing and has excellent fixation,” said Howard W. Harris, M.D., of Southlake, Texas. 
 
FX Shoulder USA Inc. is based in Dallas, Texas, and is the direct provider of FX Solutions shoulder replacement devices in the United States.  FX Shoulder USA Inc., founded in January 2018, focuses exclusively on shoulder arthroplasty. 
 
The Easytech Reversed Stemless is an investigational device limited by U.S. law to investigational use.