K2M, Inc., the largest privately held spinal device company in the world focused on developing innovative solutions for the treatment of complex spinal pathologies and minimally invasive procedures, has announced that it has received an additional FDA clearance to treat adolescent idiopathic scoliosis. The pediatric clearance applies to the company’s MESA® Deformity (ø5.5 mm), MESA Rail Deformity (ø5.5 mm), MESA Small Stature (ø4.5 mm), and MESA Rail Small Stature (ø4.5 mm) Spinal Systems.
K2M’s next generation Rail 4D™ Technology, which we covered on its launch 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. Designed to address the most complex spinal curves, the Rail provides enhanced structural rigidity while maintaining a lower-profile than traditional set screw based systems.
The top-loading MESA Spinal Systems feature Zero-Torque Technology®, applying zero torsional loads, or twisting forces, to the spine when locking the screw. Offering a variety of screw types, coupled with revolutionary instrumentation, they are uniquely designed to address the most difficult correction maneuvers while providing the surgeon the ability to one-step lock.
“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,” stated 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.”
According to Laurel Blakemore, MD, pediatric orthopedic surgeon with the Children’s National Medical Center, “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, MD, orthopedic surgeon and Medical Director, San Diego Center for Spinal Disorders.
Source: K2M, Inc.