FDA News

BioMedical Enterprises Receives FDA Clearance for Spine Use of Its Memory Metal Implants

(Oct 22, 2007)-- BioMedical Enterprises, a privately held medical device company and pioneer in orthopedic shape memory implant technology, today announced that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the OSSpine for use in anterior fixation of the cervical spine to provide enhanced biomechanical stability & bone graft retention. The patent-pending OSSpine builds on the extremity bone fusion success of BME's OSStaple and OSSplate, and joins the Step OSStaple and the OSSArc dynamic residual compression implants as the most recent additions to BME's OSSforce Fixation System.

Made of nitinol, a biocompatible alloy possessing shape memory and super-elastic properties, the OSSpine implant is inserted while in its malleable state at room temperature. Using BME's patent-pending OSSforce Implant Controller, the implant is safely heated to activate its shape change and impart compression forces across the fusion site.

During this process, the implant's legs close and it's s-shaped back shrinks providing uniform compression while the alloy's structure transforms into a state approximately 20% stronger then 316L stainless steel. The OSSpine implant actively compresses the fusion construct compensating for any graft subsidence that may occur during healing.

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