OrthoPediatrics has received 510(k) clearance from the US Food and Drug Administration (FDA) to expand the indications for its Response scoliosis system to include neuromuscular implants.
This 510(k) clearance represents a significant milestone in the company’s development toward its next generation RESPONSE Scoliosis System, Response NeuroMuscular the company said in a press release. This new system will be entirely dedicated to the treatment of neuromuscular scoliosis in paediatrics and builds on existing product offerings focused on treating this unique class of patients.
The system is being developed in conjunction with paediatric orthopaedic surgeons to address the distinct challenges in treating the neuromuscular scoliosis population. Building on the base of the company’s Response Spine System, Response NeuroMuscular will feature a complete set of implants and instruments with unique attributes that simplify insertion and specific options to address extreme hyperlordosis, the company’s press release added.
OrthoPediatrics’ executive vice president, David Bailey, stated: “The 510(k) clearance of our revolutionary implants and expanded neuromuscular indications of our Response System marks substantial progress in developing a scoliosis system dedicated to the treatment of this challenging condition. The anticipated introduction serves as the first of its kind in the industry and represents a further testament to our commitment to advance the development of products that help paediatric orthopaedic surgeons and their patients.
“While we cannot provide our expected launch timeline given the current environment, we remain undeterred on our cause of improving the lives of children suffering from scoliosis. I’m pleased by the resolve of all our associates who continue to advance our business while working remotely, so that we can emerge from the COVID-19 crisis even stronger together. We wish for the safety of the healthcare community, including our surgeon customers and their patients, during these challenging times.”