Zimmer Biomet wins FDA nod for Sidus stem-free shoulder system (MassDevice)
Zimmer Biomet (NYSE:ZBH) said today it won FDA clearance for its Sidus stem-free shoulder system.
The newly cleared Sidus system is designed as a total shoulder arthroplasty solution for patients with good bone stock with either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or those who’ve had previous surgeries of the shoulder that don’t compromise fixation, the Warsaw, Ind.-based company said.
“The Sidus stem-free shoulder system offers a novel approach to total shoulder arthroplasty requiring minimal bone resection. The Sidus system is designed to reduce pain and restore range of motion and is clinically proven to help suitable patients,” Dr. Ryan Krupp of Louisville, Ky.’s Norton Orthopedic Specialists said in a prepared statement.
Zimmer Biomet’s Sidus system is designed to anatomically restore a patients anatomy while preserving bone stock and allowing for better post-operative patient outcomes. The company plans to launch the system in the first quarter of this year.
“The FDA clearance of the Sidus stem-free shoulder system comes at a time when Zimmer Biomet is accelerating the pace of innovation. We launched Sidus in Europe in 2012 and initiated a clinical study in the U.S. in 2015. During that time, the product has demonstrated strong clinical performance. The addition of the Sidus system to Zimmer Biomet’s U.S. portfolio reinforces the Company’s leadership in the innovation of shoulder solutions,” Zimmer Biomet prez & CEO Bryan Hanson said in a press release.
Last month, Zimmer Biomet touted data from a pilot study of its nStride autologous protein solutions kit for treating osteoarthritis of the knee.