K2M Group Holdings 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 (DDC) Philosophy & Technique.
Image: K2M receives FDA approval to enhance its MESA platform. Photo: Courtesy of yodiyim/FreeDigitalPhotos.net.
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.
Akron Children’s Hospital Todd Ritzman said: “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.
K2M manufactures BACS Patient-Specific Rods and Rails using a machine rolling method, replacing the manual three-point bending method that often reduces rod fatigue strength.
By incorporating data from BACS Surgical Planner—part of K2M’s comprehensive BACS Digital Platform— rods and rails can be manufactured with complex multi-contoured designs. BACS Patient-Specific Rods and Rails can be used with the MESA, EVEREST, and DENALI Spinal Systems.
BACS provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.
K2M to Appear at SRS 2018
At the meeting, K2M executives will be onsite to discuss the Company’s differentiated spinal solutions, including its MESA Platform Technology, 3D-printed devices featuring Lamellar 3D Titanium Technology, and comprehensive Balance ACS (BACS) Platform.
“K2M is a proud Double Diamond Sponsor of SRS 2018,” said John P. Kostuik, MD, Chief Medical Officer, Co-founder, and Member of the Board of Directors at K2M, and Past President of the SRS.
“This year, we are excited to build upon our culture of innovation by showcasing our leading spinal solutions, most notably our Dual Differential Correction Philosophy & Technique—used in conjunction with our world-class MESA Platform Technology and Balance ACS Platform—so surgeons can correct complex spinal deformities across all three anatomical planes and help eliminate the need for further derotation maneuvers.”
Source: Company Press Release