Catalyst OrthoScience’s Reverse Shoulder Earns FDA Nod

Catalyst OrthoScience Inc. earned clearance from the U.S. Food & Drug Administration (FDA) to market its reverse shoulder system. Catalyst intends to start limited U.S. user release in the second quarter of 2021 followed by a commercial launch later in the year.
 
Catalyst can now offer a broader shoulder portfolio and multiple arthroplasty options to shoulder surgeons across the U.S. Reverse shoulder arthroplasty is estimated to encompass over 60 percent of the shoulder arthroplasty market.
 
“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,” Brian K. Hutchison, chairman and CEO of Catalyst told the press. “This is beneficial for our distributors as well, who can now help surgeons more easily meet the needs of patients.”
 
The single-tray arthroplasty system was 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.
 
The Catalyst reverse shoulder system is a total shoulder prosthesis for patients experiencing severe shoulder arthritis in conjunction with a grossly deficient or non-functional rotator cuff. In a reverse shoulder system, the design is inverted compared to a traditional anatomic total shoulder prosthesis where the articulating sphere is on the glenoid side of the joint and the mating insert is fixed into the humeral stem implant.
 
The Catalyst CSR system combines components and unique instrumentation to bring about a precise, accurate shoulder restoration. It features a stemless, ellipsoid humeral component engineered to accurately replace the elliptical shape of the patient’s native non-spherical humeral head.