04/30/2026 | Press release | Distributed by Public on 04/30/2026 15:23
Grand Rapids, MI - April 30, 2026 - Capitan Orthopedics, Inc. announced today that it has been granted Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its SupraSpacer™ implant.
Today, over 2 million people a year are diagnosed with a rotator cuff injury and over 700,000+ undergo surgery to repair a primary rotator cuff tear. But there is a massive gap in the care continuum and for decades patients with irreparable rotator cuff tears have faced a frustrating reality: few options exist to restore range of motion and relieve pain.
Traditional soft tissue procedures are not possible when the tendon is too damaged or retracted, and for most patients under age 60, a reverse shoulder replacement is not the best option. The SupraSpacer™ implant is an innovative, long-term option designed to restore joint alignment and enable pain-free range of motion, all while preserving future surgical options.