Zimmer Biomet Receives FDA Clearance for ROSA® Knee System for Robotically-Assisted Surgeries
WARSAW, Ind., Jan. 25, 2019 /PRNewswire/ -- 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® Knee System for robotically-assisted total knee replacement surgeries. ROSA Knee features 3D pre-operative planning tools and real-time, intraoperative data on soft-tissue and bone anatomy designed to improve bone cut accuracy and range of motion gap analysis to potentially improve flexion and restoration of natural joint movement.
"Complementing the skill and expertise of the surgeon with ROSA Knee's robotically-assisted technologies can improve accuracy, precision and consistency, which can improve patient satisfaction, clinical outcomes and efficiency," said Christopher J. Cannova, M.D., Washington Joint Institute at OrthoBethesda. "ROSA Knee functions as a surgical assistant that gives me the tools and real-time data to perform bone cuts with greater precision and improve patient-specific soft-tissue balancing and implant alignment, without losing my feel for a natural fit and flexion."
ROSA Knee leverages Zimmer Biomet's ROSA Robotics platform, which includes ROSA Brain for neurosurgical procedures.
"We are excited for the launch of ROSA Knee, which brings together Zimmer Biomet's robotics technology with our industry-leading Knee implants to help surgeons personalize surgical procedures for their patients," said Ivan Tornos, Group President, Orthopedics. "Zimmer Biomet is committed to leading the industry in bringing differentiated and holistic solutions to market that address the needs of our customers and improve patient outcomes."
About ROSA Knee
ROSA Knee is a robotically-assisted surgical system designed to help surgeons in performing total knee replacement surgery with features to assist with bone resections as well as assessing the state of soft tissues to facilitate implant positioning intraoperatively. The system provides a continuum of data analysis to assist in complex decision-making and enables surgeons to use computer and software technology to control and move surgical instruments, allowing for greater precision and flexibility during procedures. ROSA Knee features the Company's proprietary X-Atlas™ imaging protocol—which provides x-ray based preoperative imaging to create a 3D model and plan of a patient's bone anatomy—and intraoperative, real-time mapping of a patient's anatomy and motion to help surgeons personalize procedures and improve outcomes.
About Zimmer Biomet
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.
Cautionary Statement Regarding Forward-Looking Statements
This release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet's expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see Zimmer Biomet's periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet's filings with the SEC. Forward-looking statements speak only as of the date made. Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers of this release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this release.