Zimmer Biomet Receives FDA Clearance for Robotic ROSA One Spine System (press release)
Zimmer Biomet becomes first company in the world with 510(k) clearance for Brain, Spine and Knee offerings on one robotic platform
Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced U.S. Food and Drug Administration 510(k) clearance of the ROSA® ONE Spine System for robotically assisted minimally invasive and complex spine surgeries, strengthening the Company’s comprehensive ROSA® ONE Brain and ROSA® Knee portfolio.
ROSA ONE Spine combines robotics and navigation while delivering a unique real-time patient ‘dynamic tracking’ capability. The platform features 3D intraoperative planning software in addition to a navigation suite of technologies designed to improve implant as well as instrument placement accuracy and predictability.
“ROSA ONE Spine functions as a dual robotics and navigation technology solution for minimally invasive and complex thoracolumbar spine procedures,” said Aure Bruneau, Zimmer Biomet’s Group President, Spine, CMF and Thoracic and Surgery Assisting Technology. “We are extremely excited about the addition of ROSA ONE Spine to our already released ROSA ONE Brain and ROSA Knee Systems.”
About ROSA ONE Spine
ROSA ONE Spine is a robotic and surgical navigation system designed to aid surgeons in performing thoracolumbar minimally invasive and complex spine procedures. ROSA ONE Spine is designed to accommodate each surgeon’s surgical flow. The ROSA ONE Spine System is now available on the same platform as ROSA ONE Brain and ROSA Knee, providing the only robot hardware platform on the market to treat neurosurgical, spinal and knee pathologies. The release of ROSA ONE Spine expands the applications of the ROSA ONE Brain System that received 510(k) clearance earlier this quarter and continues to leverage the robotics platform also utilized for Zimmer Biomet’s flagship orthopedics robot, the ROSA Knee System that received 510(k) clearance and CE Mark approval this quarter. ROSA ONE Spine features a combination of robotic guidance and navigation functionality at the surgeon’s request with a seamless and flexible workflow that ensures surgeons can focus on surgical goals and patient outcomes. The robot introduces ‘dynamic tracking’ functionality that allows the robot to move with the patient, providing accuracy without the need to be attached to the patient or the surgical table. The multi function robot can increase the utilization of the robotic platform within the neurosurgical and orthopedic department, decreasing technology acquisition costs and streamlining service, repair and education.
About the Company
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office-based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.
We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.
We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.
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SOURCE Zimmer Biomet Holdings, Inc.