FDA grants OsteoSymbionics 510(k) clearance for sterile processing of ClearShield cranial implant product
Published on June 2, 2014 at 9:08 AM
OsteoSymbionics, innovative designer and manufacturer of patient-specific craniofacial implants, is pleased to announce FDA (U.S. Food and Drug Administration) 510(k) clearance for sterile processing of its signature ClearShield™ cranial implant product, utilizing a novel room temperature peracetic acid/hydrogen peroxide (PAA) vacuum vapor sterilization process. ClearShield™ received its original 510(k) clearance in 2007 to be provided to the hospital as non-sterile with instructions for on-site sterile processing using ethylene Oxide (EtO). Made from polymethyl methacrylate (PMMA), ClearShield™ implants are used in patients who have suffered disease or trauma to the skull, restoring the protective and cosmetic features of the individual's own bone.
Dorothy C Baunach, CEO of OsteoSymbionics says, "With more and more hospitals discontinuing on-site use of EtO sterilization, it was becoming harder to get our implants to patients in need without the ability to deliver sterile product to the hospital. We required a sterilization solution that enabled us to deliver sterile product to hospitals in a timely manner and found REVOX® Sterilization Solutions', a Cantel Medical Corp. business, which offered the right technology and all the resources we needed to help our small, but well-respected company, work toward this ideal solution. We are pleased to be able fill the needs of the patients while relieving the hospital of the EtO sterilization process."