Catalyst Receives FDA 510k Clearance for its Convertible Stemmed Total Shoulder Arthroplasty System
Catalyst OrthoScience Inc. (Catalyst), a medical device company focused on the upper extremity orthopedics market, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its fully convertible stemmed total shoulder arthroplasty system with an ellipsoid anatomic head. This is the market’s first stemmed arthroplasty system featuring an ellipsoid humeral head, which allows for more accurate restoration of the natural joint kinematics compared to spherical head designs.
Catalyst expects to begin the limited U.S. release in the second quarter of 2023 followed by a larger commercial launch later in 2023.
“The addition of the fully convertible stemmed option allows Catalyst to offer a broader portfolio of arthroplasty options to shoulder surgeons and distribution partners across the market,” said Carl O’Connell, CEO and president of Catalyst. “Catalyst OrthoScience is now positioned as the only company to offer anatomically shaped non-spherical heads in both stemmed and stemless solutions. Regardless of surgeon or patient need, Catalyst offers an innovative and differentiated clinical solution, creating implants that are purposefully designed to be better.”
Read more on the new product release here