Healthcare Industry News: K2M
News Release - November 3, 2009
K2M Enters Japanese Spine MarketMESA Spinal System Clearance Enables Sale and Distribution in Japan
LEESBURG, Va., Nov. 3--(HSMN NewsFeed)--K2M, Inc., the spinal device company developing innovative and simplified solutions for the treatment of complex spinal pathologies and procedures, today announced it has entered the Japanese spine market via its breakthrough MESA® Spinal System. Similar to 510(k) clearance in the United States, the PMDA clearance allows for sale and distribution of MESA in Japan.
MESA is a revolutionary pedicle screw system featuring Zero-Torque Technology®, which applies zero torsional loads, or twisting forces, to the spine when locking the screw. Additionally, the MESA screw has the lowest profile of any pedicle screw in the global spine market. The system’s unique instruments provide surgeons with enhanced intra-operative versatility.
“We are excited to be a part of the launch of the MESA Spinal System in Japan, as the ultra low profile and Zero-Torque Technology are ideal for the smaller stature patient population,” stated Yoshitaka Noguchi, Senior Director of Surgical Spine, Inc. (S2i), K2M’s Japanese spine business partner. “We believe MESA will act as the flagship product to help establish a firm footing in Japan and open the door to introducing additional K2M products,” said Shigeo Miyata, S2i’s Representative Director.
“Receipt of regulatory approval in Japan marks an important milestone in our international strategy and will fuel our continued growth,” stated Eric Major, K2M’s President and CEO. “We are committed to expanding the availability of our innovative products throughout the world and to becoming the global leader in providing solutions for complex spinal pathologies.”
K2M, Inc. is an innovative spinal device company committed to the research, development, and commercialization of simplified solutions for the treatment of complex spinal pathologies and procedures. Chief Medical Officer, Chairman and co-founder, Dr. John Kostuik, former Chief of Spine Surgery at The Johns Hopkins University School of Medicine, drives K2M’s commitment to redefining the market. The company is recognized as a worldwide leader in providing unique technologies for the treatment of deformity, degenerative, trauma, and tumor spinal patients. K2M’s complete portfolio of next generation products includes: spinal stabilization systems, minimally invasive systems, and other advancing technologies such as motion preservation, annular repair, and nucleus replacement. Additional information is available online at www.K2M.com.
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