CAUTION: Investigational Device. Limited by Federal (or United States) Law to investigational use. (21 CFR 812.5(a)) FDA: NCT 03806842.
FX Solutions, SAS. [FX Shoulder, Inc.] Completes Easytech Reversed® Stemless IDE Enrollment in the USA
"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.