It is expected that the regulatory approval for bone grafting will be accomplished under a 510(k) within 3 months of submission through CDRH, referencing several predicate devices. Since autologous bone marrow concentrate mixed with demineralized bone are used in the same patient, FDA clearance for orthopedic use will not require any clinical testing. In vitro testing to demonstrate the recovery, viability and composition of target cells will be sufficient to support the 510(k). Virtually the same data will support a CE mark for bone grafting procedures for marketing in the European Union. A similar process will apply for the platelet-rich plasma device, which will follow shortly after the bone marrow aspirate concentrator.