Stryker’s Balloon Implant for Rotator Cuff Tears Cleared
Kalamazoo, Mich.-based Stryker has obtained FDA 510(k) clearance for InSpace, a balloon implant for arthroscopic treatment of massive irreparable rotator cuff tears.
InSpace is designed to improve shoulder motion and function without requiring sutures or fixation devices.
The implant has been in use for more than 10 years outside of the U.S., where more than 29,000 of the balloons have been implanted. Stryker acquired the technology from OrthoSpace in 2019.