Stryker (NYSE:SYK) this week announced that it received FDA de novo clearance for its balloon implant for arthroscopic treatment of massive irreparable rotator cuff tears.

Kalamazoo, Mich.–based Stryker designed the InSpace balloon implant to restore the subacromial space without requiring sutures or fixation devices. The device has demonstrated improved shoulder motion and function, according to the company.

“Current strategies treating massive irreparable rotator cuff tears often present a challenge to surgeons and may require long and frustrating rehabilitation processes for patients,” Dr. Nikhil Verma, the lead investigator in the clinical study, said in a news release. “The results of the study demonstrate the InSpace balloon is a ‘game-changer’ and presents a shorter, less invasive option that may enable sustained, clinically meaningful improvements in shoulder function and symptoms.”

Stryker acquired the arthroscopic treatment balloon implant from OrthoSpace in 2019. It has a successful clinical history of over 10 years and 29,000 balloons implanted outside of the U.S. and the level I study conducted across North America.

“We are extremely excited about the clearance of InSpace because it provides a new surgical option for surgeons to address their unmet MIRCT needs in the shoulder continuum of care,” Matt Moreau, Stryker’s sports medicine vice president and general manager, said. “We are committed to the advancement of shoulder arthroscopy, and InSpace offers a unique opportunity for us to better partner with our customers on their clinical objectives to improve patient outcomes around a very challenging pathology in the shoulder.”