3D printing industry in healthcare segment is set to see enormous growth in the future. This technology gained importance as a prototyping tool but later it emerged as a technology through which body organs are printed. Despite the enormous growth in the industry, acquiring approval from regulatory bodies is still a barrier to the manufacturers in medical application of 3D printing. Many 3D-printed medical devices have recently received the FDA’s 510(k) (Food and Drug Administration) approval. To get clearance under this process, a manufacturer must show that the printed device is considerably similar to any another device that is legally marketed in the U.S.
Recently, BioArchitects have been granted with 510(k) clearance by the FDA for their 3D printed patient specific titanium cranial/craniofacial implant device. This device is designed to repair defects and damage in patient’s head and face. This approval adds value to the company as they can market their device in the U.S. which was first of this kind. Zimmer Biomet is another company that received FDA Clearance for 3D Printed Ankle Fusion System in February 2016. This Unite3D Bridge Fixation System is developed to improve arthrodesis procedures which do not need to insert plates, screws and staples in patient’s foot and ankle.
Likewise, there are many other companies which have received FDA grants. Tissue Regeneration Systems Inc received 510K approval from Food & Drug Administration (FDA) in U.S. for its Cranial bone Void Filler product intended to be utilized in repairmen of neurosurgical burr holes. Medical Modeling Inc. receives FDA 510K approval for its VSP System.