K2M Receives FDA Clearance Including Surgical Guidance that Enhances MESA Platform

K2M (NASDAQ:KTWO) a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance, announced at the Scoliosis Research Society 53rd Annual Meeting & Course, in Bologna, Italy a U.S. Food and Drug Administration (FDA) 510(k) clearance that also provides for the Dual Differential Correction Philosophy & Technique.

As quoted in the press release:

The DDC philosophy combines rod rigidity and degree of bend with the MESA® Platform Technology, to help achieve quality outcomes in patients with sagittal imbalance. In addition, MESA can be used with the BACS® Patient-Specific Rods to help surgeons create pre-contoured rods, rails, and templates that match the surgeon’s preoperative plan.

Todd Ritzman, MD, Akron Children’s Hospital, explained, “Given the growing recognition of the importance of sagittal plane correction in idiopathic scoliosis, it is a valuable aid to objectively determine rod contour based off of a given patient’s pelvic incidence to help optimize surgical correction in the sagittal plane. The days of ‘eyeballing’ the rod contour are over.”

K2M’s MESA Platform Technology features top-loading and low-profile screws and Zero-Torque Technology® that one-step locks without applying torsional stress to the spine. The MESA Platform includes the MESA 2 Deformity Spinal System, a state-of-the-art solution for the most difficult correction maneuvers in complex spine surgery.

Click here to read the full press release.