Catalyst OrthoScience Receives FDA 510(k) Clearance of its Reverse Shoulder System

By Julie A. Vetalice

Catalyst OrthoScience Receives FDA 510(k) Clearance of its Reverse Shoulder System

Catalyst OrthoScience was granted FDA 510(k) clearance to market its reverse shoulder system. Limited U.S. launch will begin in 2Q21, followed by commercial launch later this year.

Catalyst’s reverse shoulder system is a single-tray arthroplasty system engineered to combine the most beneficial and evidence-based attributes of reverse shoulder arthroplasty design. The system offers surgeon-targeted implant positioning, a streamlined and versatile system and bone sparing implants.

“With the addition of our reverse shoulder system, Catalyst is now addressing the two fastest growing segments of the shoulder arthroplasty market – stemless anatomic and reverse TSA,” said Brian K. Hutchison, Chairman and CEO of Catalyst.

Product Labels: Shoulder Replacement

Tags: 510(k) Clearance, Regulatory