OrthoPediatrics Gains FDA Clearance for Small Stature Scoliosis System

By Julie A. Vetalice

OrthoPediatrics received FDA 510(k) clearance to market the RESPONSE 4.5/5.0mm system to treat complex scoliosis in smaller stature, younger patients. Launch is slated for 4Q18.

This new system builds on the technology of the larger RESPONSE 5.5/6.0mm version and offers a hybrid implant design, allowing either a 4.5mm rod in CoCr or 5.0mm rod in titanium or cobalt chromium/chrome, as well as multiple implant connector options and new instrumentation.

This represents the company's 26th surgical system. Three additional launches are expected within the year.

Source: OrthoPediatrics Corp.

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