K2M, Inc. (K2M), the spinal device company, has entered the Japanese spine market via its MESA Spinal System. Similar to 510(k) clearance in the US, the PMDA clearance allows for sale and distribution of MESA in Japan.
The company claims that the 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.”