What is the history of cranial remolding orthoses?
Orthotists and prosthetists have treated children with deformational plagiocephaly since the 1970s. The first article written about the use of cranial remolding orthoses to treat deformational plagiocephaly was written by Drs. Clarren, Smith, and Hanson in 1979 in a study done at the University of Washington. In 1998 the FDA ruled that cranial remolding orthoses fell into the category of Class II medical devices and required strict control standards. In order to continue providing these orthoses, centers had to apply for and receive FDA 510(k) clearance, which is an expensive and labor intensive process. Many orthotists and prosthetists stopped providing cranial remolding orthoses at that time because their design had not gone through the process of being cleared by the FDA. In July 2000, Orthomerica received 510(k) clearance to manufacture and market the STARband.
