Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that it has received full approval from the FDA to commercialize its spinal interbody product offerings for ALIF, TLIF, PLIF and Cervical procedures.
EIT Cellular Titanium® is a porous titanium structure that has been designed according to scientific insights on ideal pore shape and size to optimize bone ingrowth. Due to the availability of metal 3D printing Selective Laser Melting (SLM) technology and proprietary post-processing methods, it has been possible to create a highly porous, osteo-influential titanium scaffold for osseointegration. This EIT Cellular Titanium® structure has been applied in the complete ALIF, TLIF, PLIF and Cervical implant line, and 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 the milestone of this 510(k) approval, EIT is moving towards full commercialization effective immediately.
Guntmar Eisen, Co-Founder and CEO for EIT says “This is a major milestone for EIT. We look forward to bringing our unique technologies to the United States and partnering with top tier surgeons and institutions to bring the best results to patients that are in need of these devices.”