FDA Clears K2M’s Spinal Technology

K2M Group Holdings Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the MESA 2 Deformity Spinal System. MESA 2 is the company’s next-generation pedicle screw system designed to address the most complex spinal pathologies.

The MESA 2 Deformity Spinal System features the next-generation MESA 2 screw, a top-loading, low-profile screw that offers a dual-lead thread pattern for fast insertion. K2M’s MESA Technology also features zero-torque technology, which offers surgeons the ability to one-step lock without torsional stress being applied to the spine. Both deformity polyaxial and uniplanar screws are available in this new system.

“I am excited about MESA 2,” said Laurel C. Blakemore, M.D., chief and associate professor of pediatric orthopaedics in the department of orthopaedics at the University of Florida. “Compared to its predecessor, MESA 2’s dual-lead thread provides the opportunity for quicker screw insertion and the on/off button on the Crickets provide an easier way for the Crickets to latch on to the MESA head to help save time during correction.”

The MESA 2 instrumentation includes upgrades with increased efficiency in mind. For example, the new Quick Cricket, the next generation of K2M’s breakthrough Cricket rod reduction technology, provides quick on/off capabilities, while correcting the spine in all three planes. Additionally, the Over Cricket Final Locker allows for one-step locking over the Cricket, thus eliminating the need to partial lock, the company noted in a news release.

“FDA clearance of MESA 2 is a milestone event for K2M that further enhances our position in the global complex spine surgery market,” said Eric Major, K2M’s president/CEO. “MESA 2 carries forward the hallmarks of our MESA and Cricket rod reduction technologies, while offering new capabilities with the goal of enhancing user experience.”