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The pedicle screw system earned FDA clearance in January.
Leesburg, Va.-based K2M Group Holdings Inc., a spine technology company, has launched the Mesa 2 deformity spinal system in the United States. The pedicle screw system is designed to address complex spinal pathologies; it carries forward the hallmarks of the company’s existing complex spine Mesa technology with added capabilities. “Following a successful Alpha phase, we are excited to announce the commercial launch of our Mesa 2 deformity spinal system and the upcoming rollout across the United States,” said Eric Major, K2M’s president and CEO. “Mesa 2 is the much-anticipated upgrade to our flagship Mesa platform and is designed to save time by cutting the number of basic surgical steps in half. We take great pride in being viewed by the surgeon community as a company that is focused on innovation and differentiation, and we remain committed to developing products that will help improve the lives of patients suffering from the most complicated spinal pathologies.” “Mesa 2 includes enhancements to the original Mesa technology and instrumentation,” said Laurel C. Blakemore, M.D., chief and associate professor of pediatric orthopedics in the department of orthopedics at the University of Florida. “This new system is yet another example of K2M’s pioneering efforts to design innovative solutions for correcting spinal deformities.” The Mesa 2 deformity spinal system features the next-generation Mesa 2 screw, a top-loading, low-profile screw that offers a dual-lead thread pattern for fast insertion. K2M’s Mesa Technology also features Zero-Torque Technology®, which offers surgeons the ability to one-step lock without torsional stress being applied to the spine. Both deformity polyaxial and uniplanar screws are available in this new system. Designed to increase efficiency, Mesa 2 also features a variety of reduction and spinal manipulation instruments. Formerly called the Cricket reduction technology, the new version is called the Quicket, and it is meant to provide quick on/off capabilities while correcting the spine in all three planes. Additionally, the Over Quicket Final Locker allows for one-step locking over the Quicket, thus eliminating the need to partial lock. K2M received U.S. Food and Drug Administration 510(k) clearance for the Mesa 2 system in January.
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