Catalyst OrthoScience today announced that it received FDA 510(k) clearance for its reverse shoulder system.
The reverse shoulder system is a total shoulder prosthesis designed for severe shoulder arthritis patients with a grossly deficient or non-functional rotator cuff. The design is inverted compared to traditional anatomic total shoulder prosthesis where the articulating sphere is on the glenoid side of the joint with the mating insert fixed into a humeral stem implant.
“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,” CEO Brian Hutchinson said in a news release. “This is beneficial for our distributors as well, who can now help surgeons more easily meet the needs of patients.”
Catalyst’s reverse shoulder system is a single-tray arthroplasty system that is made to combine beneficial and evidence-based attributes of reverse shoulder arthroplasty design, according to the company. It has surgeon-targeted implant positioning, a streamlined and versatile system and bone sparing implants.
The system adds to the company’s product line, which includes the Catalyst CSR Total Shoulder System, to offer a broader shoulder portfolio and multiple arthroplasty options to shoulder surgeons in the U.S.