The first surgery was performed in the Investigational Device Exemption study of LimaCorporate's SMR Stemless Reverse Shoulder.
This randomized, multi-center comparative clinical trial is evaluating the SMR Stemless Reverse Shoulder vs. the SMR Reverse Shoulder in total reverse shoulder replacement. The study aims to enroll 200 patients at eight U.S. investigational sites with two-year follow-up.
SMR Stemless Reverse is presently approved in Europe, Mexico and selected APAC markets.
Luigi Ferrari, CEO of LimaCorporate, said, "The first successful surgery of the SMR Stemless Reverse in the clinical trial of the IDE represents another major milestone after the FDA approval we received at the end of 2020. This shows that we are on our way to making a great contribution to the U.S. orthopedic market with a device that will target the trending needs of reverse shoulder arthroplasty."