K2M Expands MESA Platform with FDA Clearance for Growing Spine Application

By Julie A. Vetalice

K2M received FDA 510(k) clearance for components for the MESA® Spinal System. This clearance enables screw and connector components to be used as a part of a growing rod construct, designed to accommodate growth in patients under 10 years old.

The growing spine application is designed to to obtain and maintain correction of severe, progressive, life threatening early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis.

The MESA line of top-loading, low-profile devices features Zero-Torque Technology® and 60° range of motion. Study results, announced in early 3Q16, suggest that use of the MESA Rail™ Deformity Spinal System may yield significantly better major curve correction than standard circular rod constructs in the treatment of Adolescent Idiopathic Scoliosis.

Sources: K2M, Inc.; ORTHOWORLD Inc.

Tags: 510(k) Clearance, Regulatory