OrthoPediatrics’ scoliosis system gains FDA clearance

The FDA granted OrthoPediatrics 510(k) clearance to expand its Response Scoliosis system to include neuromuscular implants on March 31.

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Three insights:

1. The Response NeuroMuscular system is intended for the treatment of neuromuscular scoliosis in pediatric patients.

2. The device will feature a full set of implants and instruments to facilitate insertion and help treat severe hyperlordosis.

3. A team of pediatric orthopedic surgeons is building upon OrthoPediatrics’ Response Spine system to develop the technology.

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