Emerging Implant Technologies GmbH (EIT), a German medical device maker focused exclusively on additively manufactured technologies for spinal application, reports that it has received full 510(k) approval from the US Food and Drug Administration (FDA) for its metal AM spinal cages. EIT offers a number of spinal products suitable for ALIF (Anterior Lumbar Interbody Fusion), TLIF (Transforaminal Lumbar Interbody Fusion), PLIF (Posterior Lumbar Interbody Fusion) and Cervical procedures.
The implants combine an osteo-influential scaffold with designs which address spinal alignment, and are produced in EIT Cellular Titanium®, a porous titanium structure designed according to research on the ideal pore shape and size to optimise osseointegration (bone in-growth). Each implant combines an osteo-influential scaffold with designs to address spinal alignment.
All of the company’s implants are produced using Selective Laser Melting, and are said to have been subject to a number of clinical case studies which demonstrate extensive bone in-growth in a short time frame. They have been used in over 10,000 cases in over fifteen countries including Germany, France, Australia, Korea and the Netherlands. Following the 510(k) approval, EIT stated it is moving towards full commercialisation.
Guntmar Eisen, EIT Co-Founder and CEO, stated, “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.”