Warsaw, Indiana, June 1, 2015 – OrthoPediatrics Corp. announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market the ResponseTM Spine System. This system is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/ilium and hook fixation
T1-L5) in pediatric patients is indicated as an adjunct to fusion to treat Adolescent Idiopathic Scoliosis. The device is intended to be used with autograph and/or allograft.
The Response Spine System was designed specifically for pediatric spinal deformity patients, and it is one of only a few spinal systems on the market to have a specific pediatric FDA clearance. The Response 5.5/6.0 Spine System which includes a 5.5/6.0mm rod offering with an innovative set screw design and versatile instrumentation can handle very complex spinal deformity procedures. This new system expands the current OrthoPediatrics Response Spine offering which has had more than 400 surgical procedures performed to date.
“The Response Spine System was developed with pediatric orthopedic surgeons and for pediatric surgeons to provide the pediatric spinal deformity patients exactly what they need,” said Jeff Smithey, Vice President of Spine for OrthoPediatrics, “and this innovative technology from OrthoPediatrics further represents our commitment as the only company completely focused on providing high quality solutions for pediatric orthopedic patients.”
About OrthoPediatrics Corp
OrthoPediatrics Corp is a privately held global leader of orthopedic surgical systems focused exclusively on providing pediatric orthopedic surgeons quality and innovative products in children’s hospitals. The Company is the only end-to-end provider of pediatric surgical implants and instruments and has the only global pediatric sales and distribution system in the orthopedic industry. Founded in 2007, the Company has experienced significant growth with the introduction of 18 surgical systems and distribution in more than 30 countries.