K2M (NSDQ:KTWO) said today it won FDA 510(k) clearance for screw and connector components used as part of the company’s Mesa spinal system.
The newly cleared components from the Leesburg, Va.-based company are designed to be used as part of a growing rod construct designed to accomodate growth in pediatric patients 10 years and younger.
“We are excited to receive FDA clearance for a growing spine application, which will provide surgeons with a new treatment option for correcting spinal deformity among a specific subset of the pediatric spinal deformity population,” prez & CEO Eric Major said in a press release
The company said that with its cleared devices, operating physicians can use selective components fron traditional fusion constructs to create growth-enabling construction, which allows implants to be surgically lengthened as patients grow.
“This regulatory milestone, coupled with our recent data announcement of findings surrounding our motion-preserving scoliosis technology, reinforce our ongoing commitment to achieving the highest level of excellence in developing innovative technologies that provide enduring treatments for young patients suffering from complex spinal deformities, such as early-onset scoliosis and adolescent idiopathic scoliosis,” Major said in a prepared statement.
In January, K2M said it won CE Mark approval in the European Union for its Rhine cervical disc system designed to treat degenerative disc disease.
The company said the newly cleared device features a 1-piece compressible polymer core, dome-shaped, plasma-coated endplates and a central-split keel, formed through proprietary molding technology to minimize wear between the core and endplates
K2M said its newly released system integrates trialing and keel cutting into a single instrument, and has a built-in adjustable stop to allow for custom anterior or posterior positioning.
