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Reimbursement / Regulatory

OrthoPediatrics Gains FDA Clearance for Small Stature Scoliosis System -

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. (OrthoPediatrics Corp., 10/19/18)