20 April 2021
LimaCorporate is proud to announce the first surgery performed in the Stemless Reverse Shoulder System Investigational Device Exemption (IDE) study.
LimaCorporate is proud to announce the first surgery performed in the Stemless Reverse Shoulder System Investigational Device Exemption (IDE) study.
The IDE, approved by FDA last November, allows LimaCorporate evaluate the safety and effectiveness of our Stemless Reverse Shoulder System compared to our Reverse Shoulder System in a randomized, multi-center comparative clinical trial.
This study is an exceptional opportunity for LimaCorporate as there are currently no stemless reverse implants cleared for use by the FDA. LimaCorporate’s IDE study on the Stemless Reverse System, which aims to enroll 200 patients at eight U.S. investigational sites with two-year follow-up, is a pivotal first step to address this unmet need in the U.S. shoulder arthroplasty market.
The IDE Study makes us even more confident about the future: new products, new projects, and activities are growing and taking shape.
Read the full press release here
