FDA Clears Zimmer Biomet’s Sidus Stem-Free Shoulder System

Zimmer Biomet Holdings Inc., a global leader in musculoskeletal healthcare, has received U.S. Food and Drug Administration (FDA) clearance for 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 Stem-Free Shoulder system is designed to anatomically restore a patient’s anatomy, preserve bone stock and allow for improved pre- to post-operative patient outcomes.^1,2 The Sidus system will be available in the United States beginning in the first quarter of 2018.
 
“The Sidus Stem-Free Shoulder system offers a novel approach to total shoulder arthroplasty requiring minimal bone resection,” said Dr. Ryan Krupp, orthopedic surgeon at Norton Orthopedic Specialists in Louisville, Ky. “The Sidus system is designed to reduce pain and restore range of motion and is clinically proven to help suitable patients.”^1,2
 
“The FDA clearance of the Sidus Stem-Free Shoulder system comes at a time when Zimmer Biomet is accelerating the pace of innovation,” said Bryan C. Hanson, Zimmer Biomet president and CEO. “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.”  
 
Founded in 1927 and headquartered in Warsaw, Ind., Zimmer Biomet designs, manufactures and markets orthopedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products. The company’s products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Zimmer Biomet has operations in more than 25 countries around the world and sells products in more than 100 countries.

References
1. Multicenter Trial of the Sidus® Stem-Free Shoulder Arthroplasty System (Protocol CIU2012-12E/G130026, “IDE”). 
2. Sidus® Stem-Free Shoulder: A Multicenter, Prospective, Non-Controlled Post Market Clinical Follow-up Study (Clinical Investigation Plan CME2012-01E, “PMCF”).