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K2M receives FDA clearance for pedicle screw system

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K2M Group Holdings recently announced it has received 510(k) clearance from the FDA to market the MESA 2 Deformity Spinal System.

The MESA 2 is the company’s next-generation pedicle screw system designed to address the most complex spinal pathologies, according to a press release.

The system features the new MESA 2 screw — a top-loading, low-profile screw that offers a dual-lead thread pattern for fast insertion, according to the release.

MESA 2 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.

Reference: www.k2m.com.