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Product / Company Performance

Bio2 Gains Approval to Study Vitrium in Interbody Fusion -

Bio2 Technologies received FDA approval to commence enrollment in an Investigational Device Exemption clinical study of Vitrium bioactive glass as a structural cervical interbody fusion device. Vitrium is presently FDA 510(k) cleared for marketing as a bone graft substitute. This one-year randomized, controlled, non-inferiority pivotal study will evaluate the biomaterial as a device that gradually converts to a patient's own bone, offering an alternative to PEEK and titanium to achieve fusion.(Bio2 Technologies, Inc., 11/13/18)