Stryker Granted FDA 510(k) Clearance for InSpace Balloon Spacer

By Julie A. Vetalice

Stryker Granted FDA 510(k) Clearance for InSpace Balloon Spacer

Stryker announced FDA clearance of InSpace, the first balloon implant for arthroscopic treatment of massive irreparable rotator cuff tears (MIRCTs). The technology was acquired from OrthoSpace in 2019 and is the first of its kind in the U.S. market. The InSpace balloon implant has a long successful clinical history of over 10 years and 29,000 balloons implanted outside of the US, as well as the Level I study conducted across North America.

The InSpace balloon implant is designed to restore the subacromial space without requiring sutures or fixation devices and has been demonstrated to improve shoulder motion and function.

"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," said Matt Moreau, Stryker's Sports Medicine Vice President and General Manager. "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."

Source: Stryker

Product Labels: Traditional Soft Tissue Repair