OsteoSymbionics Announces Significant FDA 510(k)
OsteoSymbionics, innovative designer and manufacturer of patient-specific craniofacial implants, is pleased to announce the US FDA 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.”
OsteoSymbionics is dedicated to the design, development, and fabrication of the highest quality patient-specific craniofacial implants for patients with severe cranial and facial damage. The company’s hard-tissue implants are used by top surgeons at America’s leading hospitals and abroad. More than 850 patients have benefitted from ClearShield (PMMA) and PK-Shield implants made from Polyether ether ketone (PEEK). OsteoSymbionics also makes an implantable silicone product, STT, designed to correct temporal hollowing.
Using state-of-the-art digital technology and custom software, our biomedical engineering experts work closely with classically trained sculptors and artisans to create implants that precisely match both the surgeon’s plan and the patient’s needs. Cases requiring implants above average in size or difficulty of design are a specialty.
OsteoSymbionics is an awarded supplier of its Craniomaxillofacial (CMF) products to Novation, a premiere group purchasing organization serving more than 60,000 members. Founded and located in Cleveland, OH, OsteoSymbionics is active in the region’s vibrant community of businesses focused on bioscience technologies and healthcare services and products. The company is housed within the multi-tenant facility of the Manufacturing Advocacy and Growth Network (MAGNET).
For more information about OsteoSymbionics and its products, please call 877-881-6899 or visit our website at www.osteosymbionics.com. Contact information Dorothy C. Baunach, CEO, OsteoSymbionics LLC, 216-881-8500,
db@osteosymbionics.com.
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