Emerging Implant Technologies GmbH (EIT), based in Wurmlingen, Germany, is announcing that it has received 510(k) clearance from the FDA to commercialize its spinal interbody products for ALIF (anterior lumbar interbody fusion), TLIF (thoracic lumbar interbody fusion), PLIF (posterior lumbar interbody fusion) and cervical procedures.
EIT: 510(k) Clearance for Full 3D Printed Spine Cage
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According to the company, “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 in growth throughout the total implants in the cervical and lumbar spine in a short time frame.”
Guntmar Eisen, co-founder and CEO for EIT said, “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.”
Eisen told OTW, “Coming to the U.S. brings many challenges for a small German company.”
“First, we knew our products provide very compelling traits to the surgeon including enhanced imaging due to its porosity, and an ideal pore shape and size that encouraged bone through-growth allowing for the reduced need of expensive biologics.”
“It certainly helps that we have a strong clinical history of over 15,000 implants worldwide.”
“For introducing the products to the market, we chose to engage with Ortho Sales Partners, rather than recruit an expensive direct sales leadership team. That choice proved to be a very cost efficient and effective model resulting in exceeding our initial expectations. We are extremely encouraged with the initial results and also believe we are well positioned for continued success.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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