Tornier Gets FDA Green Light for Simpliciti Shoulder System
Dutch joint replacement company Tornier received FDA clearance for its Simpliciti shoulder system. The device is designed to preserve native bone and avoid further damage to surrounding soft tissue, the firm said Tuesday.
Simpliciti is a total shoulder arthroplasty system intended to treat severe shoulder joint pain, compromised range of motion, loss of strength and functionality, Tornier said. It includes a novel humeral component that allows surgeons to deliver precise anatomic placement without the constraints of fixed inclinations, medial offset or posterior offset, the firm added.
To demonstrate the system’s efficacy, Tornier conducted a trial with U.S. surgeons from 2011 through 2014, including two-year follow-up of shoulder procedures, the company said. — Kellen Owings