K2M Gets Pediatric Clearance for Scoliosis Treatment Technology

Leesburg, Va.-based K2M Inc. has received pediatric clearance from the U.S. Food and Drug Administration (FDA) for its Mesa line of devices for the treatment of adolescent idiopathic scoliosis. The cleared devices are the Mesa Deformity, Rail Deformity, Small Stature, and Rail Small Stature Spinal Systems.

Scoliosis is a condition of a lateral curvature of the spine. In order to be deemed “adolescent” scoliosis, the patient must be between 10 and 18 years old. Idiopathic scoliosis, the most common type, is when the cause of the deformity is not known.

“K2M is deeply committed to advancing care for scoliosis patients and we have developed technologies like Mesa and Rail to put new capabilities into the hands of surgeons who treat the most complex spinal deformities,” said Eric Major, K2M’s president and CEO. “We are extremely pleased by the new indication and this milestone achievement allowing K2M to provide innovative solutions for surgeons treating pediatric patients.”

K2M’s next-generation Rail 4D technology, which debuted in July, is inspired by structural I-beam geometry and provides an alternative to the first generation round spinal rods offered with other products in the marketplace. The Rail is designed to address the most complex spinal curves by providing enhanced structural rigidity while maintaining a lower-profile than traditional set screw-based systems.

The top-loading Mesa Spinal Systems feature K2M’s Zero-Torque Technology, which reportedly applies zero torsional loads, or twisting forces, to the spine when locking the screw. The system comes with a variety of screw types, and is designed to address the most difficult correction maneuvers while providing the surgeon the ability to one-step lock.

According to Laurel Blakemore, M.D., pediatric orthopedic surgeon with the Children’s National Medical Center in Washington D.C., “The clearance of these pedicle screw technologies is an encouraging movement forward in the treatment of pediatric spinal patients. The FDA’s pediatric clearance of K2M’s Mesa, Mesa Small Stature, and Rail supports the development of technology to treat pediatric patients with severe spinal deformity.”

“This clearance is exciting and reflects willingness on the part of regulatory agencies around the world to clear devices and technologies that address a wide range of applications in the treatment of pediatric spinal disorders,” added Behrooz Akbarnia, M.D., orthopedic surgeon and medical director at the San Diego Center for Spinal Disorders in San Diego, Calif.

K2M’s technology targets the treatment of complex spinal pathologies and minimally invasive procedures.

Photo of Mesa Rail Deformity System courtesy of K2M Inc.