Kids can now benefit from K2M, Inc.’s MESA Deformity spinal system.
K2M’s MESA Cleared for Kids
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On September 18, the company announced additional FDA 510(k) 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.
According to Laurel Blakemore, M.D., 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 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, San Diego Center for Spinal Disorders.
The Rail 4D technology was introduced in July. According to the company, the technology was 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 system features the company’s “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 instrumentation, the system allows surgeons the ability to one-step lock.
K2M’s President and CEO, Eric Major, said the company is deeply committed to advancing care for scoliosis patients. “We have developed technologies like MESA and Rail to put new capabilities into the hands of surgeons who treat the most complex spinal deformities.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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