K2M Receives FDA Clearance for BACS Patient-Specific Module

K2M Group Holdings Inc., a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for BACS Patient-Specific devices. With the BACS Surgical Planner, surgeons can create pre-contoured rods, rails, and templates that match the surgeon’s preoperative plan. This is K2M’s fifth module within the BACS platform, and its first clearance for patient-specific devices.
 
“Templated, pre-contoured rods have made a big difference to my practice,” said Carmen Petraglia, M.D., spine surgeon at South Hills Orthopaedic Surgery Associates in Pittsburgh, Pa. “Pre-contoured rods take out a huge question factor in terms of time. With pre-contoured rods, you save time by not having to contour your rods during 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, 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.
 
“Personalized solutions for treating spinal deformity is a positive development for patients who may benefit from having surgery tailored to their unique needs,” said K2M Chairman, President, and CEO Eric Major. “K2M is excited to realize this vision, as evidenced by our first regulatory clearance for BACS Patient-Specific devices. When coupled with our BACS Surgical Planner, K2M is well-positioned to become an industry leader in creating patient-specific devices, with an ultimate goal of facilitating 3D spinal balance and improved quality of life.”
 
K2M’s BACS Surgical Planner provides surgeons with a comprehensive tool to preoperatively measure and record a patient’s skeletal parameters to obtain baseline measurements that aid in the creation of BACS Patient-Specific Rods. BACS Surgical Planner is part of K2M’s Balance ACS (or BACS) platform, which provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach in the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.
 
K2M Group Holdings Inc. designs, develops, and commercializes complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. The company is based in Leesburg, Va.