FX Shoulder Solutions has received FDA 510(k) clearance of its Easytech Reversed system for shoulder replacements.
Easytech Reversed is the first FDA-cleared stemless reverse shoulder arthroplasty system in the U.S., according to a Nov. 5 news release from FX Shoulder Solutions.
The system uses humeral anchor base architecture and is intended to engage proximal humeral bone near the cortical boundaries, eliminating the need for a conventional diaphyseal stem.
The company conducted a multicenter investigation across seven sites and involved 90 patients. Study follow-up was completed in 2023, contributing to the clinical evidence supporting the development, regulatory evaluation and clearance of Easytech Reversed, the release said.
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