Will Sidus Take a Load off Zimmer & #039;s Shoulders?

Zimmer Biomet didn't have the best year in 2017, but the company's first FDA clearance of 2018 could be a sign of better things to come for the Warsaw, IN-based orthopedic device maker. FDA cleared the Sidus Stem-Free Shoulder system as a total shoulder arthroplasty solution for patients with good bone stock that have either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head, or who had previous surgeries of the shoulder that do not compromise the fixation. The Sidus system is designed to anatomically restore a patient's anatomy, preserve bone stock, and allow for improved patient outcomes. Zimmer Biomet said it will begin selling the Sidus system in the United States during the first quarter. The product has been on the market in Europe since 2012, and the company initiated a U.S. trial of the system in 2015. The regulatory nod for the Sidus system comes within a month of the company getting a new president and CEO. Bryan Hanson took the reins Dec. 19. Daniel Florin, who had served as interim CEO, will continue in his role as senior vice president and CFO. David Dvorak resigned from the company's top position in July amid investor frustration. FDA hit Zimmer Biomet with an unusually long Form 483 in December 2016 based on quality control problems at the company's legacy Biomet facility. In January 2017 the company said it would invest $170 million to "harmonize and optimize" its supply chain and manufacturing and quality systems. Â...
Source: MDDI - Category: Medical Devices Authors: Tags: Orthopedics Source Type: news