FDA Clears Catalyst OrthoScience’s Reverse-Shoulder System
The FDA has given Catalyst OrthoScience 510(k) clearance for its Catalyst reverse-shoulder arthroplasty system.
The reverse-shoulder system is a total shoulder prosthesis intended for use in patients with severe shoulder arthritis and a deficient or nonfunctional rotator cuff.
The single-tray system features surgeon-targeted implant positioning as well as bone-sparing implants. The company is planning a limited U.S. release in the second quarter followed by a full commercial launch later in the year.