Cantel Medical and OsteoSymbionics have announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for OsteoSymbionics' signature ClearShield product.
Made from polymethyl methacrylate, ClearShield is the first Class II medical device approved by the FDA using REVOX Sterilization Solutions’ room temperature peracetic acid/hydrogen peroxide vacuum vapor sterilization process.
ClearShield implants have been designed for use in patients who have suffered trauma to the skull, restoring the protective and cosmetic features of the individual’s own bone.
OsteoSymbionics CEO Dorothy Baunach said that REVOX is the perfect solution for the sterile processing of its ClearShield craniofacial implants.
"More and more hospitals are discontinuing on-site use of ethylene oxide (EtO) sterilization and we needed a solution that would offer fast contract service turnaround and potential for processing at our manufacturing site as well," Baunach added.
"After much research into sterile processing options we discovered REVOX, with the right technology and all the resources we needed to help our small, but well-respected company, work toward this ideal solution."