K2M receives paediatric FDA clearance for Mesa and Rail 4D spinal systems


The US Food and Drug Administration (FDA) has given additional clearance to K2M for the treatment of adolescent idiopathic scoliosis. The paediatric clearance applies to the company’s Mesa Deformity (ø5.5mm), Mesa Rail Deformity (ø5.5mm), Mesa Small Stature (ø4.5mm), and Mesa Rail Small Stature (ø4.5mm) spinal systems.  

The Mesa spinal systems feature Zero-Torque Technology, applying zero torsional loads, or twisting forces, to the spine when locking the screw.

According to K2M, the next generation Rail 4D technology provides enhanced structural rigidity while maintaining a lower-profile than traditional set screw based systems.

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

“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 paediatric spinal disorders,” said Behrooz Akbarnia, orthopaedic surgeon and medical director, San Diego Center for Spinal Disorders, California, USA.