The FDA granted 510(k) clearance to Catalyst OrthoScience’s uncemented humeral implant, a new product in the company’s Catalyst CSR Total Shoulder System.

The device uses a titanium plasma spray coating and press-fit fixation to give it initial stability without the need for bone cement.

The implant is composed of a non-spherical head designed to restore joint motion in the shoulder and the humeral bone’s large rounded head.