Your infant’s cranial helmet treatment will be provided by the STAR Cranial Center of Excellence. The STAR Cranial Center of Excellence exclusively utilizes cranial helmets manufactured by Orthomerica Products, Inc, the largest cranial remolding manufacturer in the world. Currently, Orthomerica is one of only two manufacturers that have FDA clearance to fabricate cranial helmets. These highly specialized custom cranial helmets require multiple design options, clinical expertise, and technology in order to achieve optimal clinical outcomes for this vulnerable patient population. The STAR Cranial Center of Excellence has a working relationship with UT Health Science Center (UTHSC) but is not associated with UTHSC.
The custom post-operative cranial remolding orthosis (cranial helmet) is a Class II device regulated by the FDA, which requires stringent quality, safety, and labeling information. Cranial helmets can only be manufactured by companies that have 510k clearance from the FDA. In June of 2009, Orthomerica Products, Inc was awarded FDA clearance for its cranial helmets. It is important to note that the FDA does not consider these devices to be investigational.