The RESPONSE Neuromuscular has received the US FDA 510(k) approval in 2020
OrthoPediatrics, a company focused on paediatric orthopaedics, has introduced its RESPONSE Neuromuscular Scoliosis System.
The RESPONSE Neuromuscular (RESPONSE NM) has received the US FDA 510(k) approval in 2020, and the company is planning for a full-scale domestic launch in the summer.
The system represents the latest addition to the RESPONSE Scoliosis platform, designed to treat paediatric patients.
It is designed for the treatment of neuromuscular scoliosis and was supported by the paediatric orthopaedic surgeons to address the treatment challenges.
OrthoPediatrics scoliosis vice president Jeff Smithey said: “We are excited about the launch of the RESPONSE NM and this first of its kind offering completely focused on implants and instruments for treating neuromuscular scoliosis.
“Our platform of neuromuscular solutions further demonstrates how OrthoPediatrics is uniquely focused on development of products that help pediatric orthopedic surgeons and their patients around the world.”
RESPONSE NM was built based on the company’s RESPONSE Spine System, and features a complete set of implants and instruments.
The device has advanced attributes that simplify insertion and specific options to address extreme hyperlordosis and sacral/pelvic fixation.
The RESPONSE NM system is also designed to works with other products in the company’s Scoliosis platform, including the BandLoc Sublaminar banding system, and FIREFLY 3D printed pedicle screw guides, said the company.
Shriner’s Hospital for Children, St. Louis, Missouri, paediatric orthopaedic surgeon and chief of staff Scott Luhmann has worked as part of the design team.
Scott Luhmann said: “Neuromuscular scoliosis patients can present with a wide array of extreme 3-dimensional deformities, which can require highly individualized and complicated surgical treatment.
“The addition of the Neuromuscular Scoliosis System to the OrthoPediatrics RESPONSE offering was designed to improve the speed and efficacy of the instrumentation, correction and stabilization of these complicated deformities, with the aim of optimizing outcomes.
“This now makes the OP RESPONSE system the ideal one for all types of pediatric spinal deformity.”
Founded in 2006, OrthoPediatrics currently markets 35 surgical systems for the pediatric orthopedic market.
The product offerings cover trauma and deformity, scoliosis, and sports medicine/other procedures.