Kalamazoo, MI -- Stryker Orthopaedics, a division of Stryker Corporation (NYSE:SYK), today announced that its 510(k) submission for the Mako total knee application has received market clearance by the U.S. Food and Drug Administration.
This clearance expands Stryker's current Mako offering of partial knee and total hip applications to provide a comprehensive solution in the robotic reconstructive service line. "The ability to include a Mako total knee application with our market leading Triathlon Total Knee System represents a key milestone in reconstructive surgery," said David K. Floyd, Group President, Orthopaedics. "We are excited about the opportunity to transform orthopaedics by furthering the growth of robotic-arm assisted surgery, and by enhancing the surgeon and patient experience."
With the clearance of the total knee application, Stryker is preparing to initiate a limited market release by year end.
This press release contains information that includes or is based on forward-looking statements within the meaning of the federal securities law that are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: weakening of economic conditions that could adversely affect the level of demand for our products; pricing pressures generally, including cost-containment measures that could adversely affect the price of or demand for our products; changes in foreign exchange markets; legislative and regulatory actions; unanticipated issues arising in connection with clinical studies and otherwise that affect U.S. Food and Drug Administration approval of new products; changes in reimbursement levels from third-party payors; a significant increase in product liability claims; the ultimate total cost with respect to the Rejuvenate and ABG II matter; the impact of investigative and legal proceedings and compliance risks; resolution of tax audits; the impact of the federal legislation to reform the United States healthcare system; changes in financial markets; changes in the competitive environment; our ability to integrate acquisitions; and our ability to realize anticipated cost savings as a result of workforce reductions and other restructuring activities. Additional information concerning these and other factors is contained in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
Stryker is one of the world's leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine, which help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.