www.fdanews.com/articles/207101-catalyst-orthosciences-shoulder-arthroplasty-software-gets-fdas-510k-clearance
Catalyst OrthoScience’s Shoulder Arthroplasty Software Gets FDA’s 510(k) Clearance
March 24, 2022
The FDA has granted 510(k) clearance to Catalyst OrthoScience’s Archer 3D Targeting planning software for shoulder arthroplasty procedures.
The pre-operative software, which was licensed from the Belgian medical technology company 3D-Side, identifies the best fit for initial placement of the shoulder implants, which surgeons can then further refine, the Naples, Fla.-based company said.
Catalyst OrthoScience said it is launching a limited release of the planning software to test it in clinical settings.