BIOSTRUCTURE definition
BIOSTRUCTURE means a LICENSED PRODUCT intended for use (i) as bone replacement or bone void filler or in bone repair, (ii) in orthopedic products such as internal fixation devices, cartilage and joints, and (iii) as dental devices both above and below the gum line. A BIOSTRUCTURE may contain pharmaceuticals or other active or inactive ingredients. Notwithstanding the above, a BIOSTRUCTURE shall not mean LICENSED PRODUCT intended for use as neural tissue or repair of neural tissue. EXCLUDED FIELDS also include matrices, scaffolds or other supportive structures which may be used in combination with cells, tissues or organs; products for the repair of vascular or tubular tissues; organs including those incorporating a temporary or permanent cell line to produce naturally occurring substances that substitute for organ function; organs and tissues used as drug delivery systems; skin healing and replacement products; those elements of in vitro diagnostic devices which interact with human biological materials and contain the reactants specific to the test being performed; products intended for use as neural tissue or repair of neural tissue; and diagnostic scaffolds. ExOne EXCL P 6-15-2011