www.fdanews.com/articles/204111-shoulder-innovations-gets-510k-clearance-for-arthroplasty-system
Shoulder Innovations Gets 510(k) Clearance for Arthroplasty System
August 25, 2021
Holland, Mich.-based Shoulder Innovations has received 510(k) clearance from the FDA for its InSet reverse shoulder replacement system.
The InSet system includes artificial intelligence-based 3D preview software that helps clinicians with precise placement of the implant.
The system, which includes a range of implant types, was designed to simplify surgical procedures, potentially reducing complications and increase implant longevity, the company says.