K2M announces FDA 510(k) clearance for patient-specific module

K2M Group Holdings Inc. announced it has received FDA 510(k) clearance for the Balance ACS patient-specific devices.

According to a company press release, the Balance ACS (BACS) surgical planner allows surgeons to create pre-contoured rods, rails and templates that match their preoperative plan. The surgical planner offers surgeons a tool that preoperatively measures and records a patient’s skeletal parameters to collect baseline measurements that assist in the creation of the BACS patient-specific rods. The patient-specific rods and rails may be used in combination with Mesa, Everest and Denali spinal systems. The surgical planner is reportedly the fifth module in the BACS platform and its first clearance for patient-specific devices.

“Personalized solutions for treating spinal deformity is a positive development for patients who may benefit from having surgery tailored to their unique needs,” Eric Major, K2M chairman, president and CEO, said in the release. “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 3-D spinal balance and improved quality of life.”

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