Capitan Orthopedics Receives FDA Breakthrough Device Designation for SupraSpacer Implant
Capitan Orthopedics, Inc. has announced that its SupraSpacer™ implant has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This implant is designed to address irreparable rotator cuff tears, a condition affecting over 2 million people annually in the U.S., with more than 700,000 undergoing surgery each year. The SupraSpacer™ offers a biomechanical solution that aims to reduce pain and improve patient function by maintaining joint alignment and allowing a full range of motion. The implant is particularly beneficial for patients under 60, for whom traditional soft tissue procedures or reverse shoulder replacements are not ideal. Capitan Orthopedics, backed by Genesis Innovation Group, aims to fill a significant gap in the care continuum for these patients.