EIT receives US FDA 510(k) approval for entire 3D-printed cage portfolio

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Emerging Implant Technologies (EIT) has received full approval from the US Food and Drug Administration (FDA) to commercialise its spinal interbody product offerings for anterior, transforaminal and posterior lumbar interbody fusion procedures, and cervical procedures.

EIT cellular titanium is a porous titanium structure that has been designed to optimise bone ingrowth. Using metal 3D printing selective laser melting (SLM) technology and proprietary post-processing methods, the company has created a highly porous, osteo-influential titanium scaffold for osseointegration. According tio a company release, clinical case studies and retrieval analysis demonstrate extensive bone ingrowth throughout the total implants in the cervical and lumbar spine in a short time frame.

EIT cellular titanium Interbody cages target for smart spinal fusion in combining an osteo-influential scaffold with designs to address spinal alignment. The implants have been used in over 10,000 cases in over 15 countries including Germany, France, Australia, Korea and the Netherlands. With this approval, EIT is to move towards full commercialisation.

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