K2M Group Holdings announced at the Scoliosis Research Society (SRS) 51st Annual Meeting & Course in Prague, Czech Republic that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for screw and connector components toward a growing spine application 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.
“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,” said Eric Major, K2M’s President and CEO.
K2M’s growing spine application features closed-head screws and previously-cleared axial connectors, providing 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.
With this growing spine application, surgeons can utilize 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 also offers 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.
K2M’s growth guidance implants may be used with any cleared K2M rod construct ranging in diameter from 4.5 mm to 6.35 mm. K2M’s growth rod conversion implants may be used with 4.5 mm and 5.5 mm rod constructs.
Major added, “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.”
In July, K2M announced findings from a multi-year study surrounding the Company's recently-acquired motion-preserving scoliosis technology* from K-Spine.
The study found that the innovative apical fusion technique achieved corrected deformity profiles in AIS patients and maintained mobility of non-fused segments with a lower implant density, sparing 52 percent of the spanned area from fusion.