K2M has received 510(k) clearance from the US Food and Drug Administration (FDA) for screw and connector components for its Mesa spinal system. This clearance enables these screw and connector components to be used as a part of a growing rod construct designed to accommodate growth in patients under 10 years of age. The clearance was announced at the Scoliosis Research Society 2016 Annual Meeting in Prague, Czech Republic.
K2M’s growing spine application features closed-head screws and previously-cleared axial connectors, designed to provide a surgical solution for patients less than 10 years of age to obtain and maintain correction of severe, progressive, life threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis.
This growing spine application is intended to allow surgeons to utilise components from a traditional fusion construct for a growth-enabling construction, allowing implants to be surgically lengthened on a periodic basis as the patient grows. This growing spine application is also designed to offer a growth guidance option, combining standard instrumentation and placement of unlocked closed-head screws at non-fusion levels, to allow for rod passage as the patient grows.
According to a company release, K2M’s growth guidance implants may be used with any cleared K2M rod construct ranging in diameter from 4.5mm to 6.35mm. K2M’s growth rod conversion implants may be used with 4.5mm and 5.5mm rod constructs.
