K2M Expands MESA Platform with FDA Clearance for Sagittal Imbalance Application

By Julie A. Vetalice

K2M received an additional FDA 510(k) clearance for the MESA® Spinal System, providing for use of the Dual Differential Correction (DDC) Technique to treat sagittal imbalance in idiopathic scoliosis patients.

According to K2M, DDC combines rod rigidity and degree of bend with the MESA platform to achieve sagittal plane correction.

As part of the process, MESA can be used with K2M’s BACS® Patient-Specific Rods to help surgeons create pre-contoured rods, rails and templates to match a preoperative plan.

The MESA line of top-loading, low-profile devices features Zero-Torque Technology® and 60° range of motion.

Sources: K2M; ORTHOWORLD, Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory