Spinal Elements Announces FDA 510(k) Clearance of Lucent® 3D Additive Manufactured Interbody Devices

Spinal Elements, a spine technology company, today announced the first 510(k) clearance in the Lucent® 3D line of 3D-printed interbody devices.

Spinal Elements, in developing lucent 3D, has taken advantage of the unique capabilities of 3D printing by printing a functionally unique multi-component device in a single printing step.  The resulting Lucent 3D implant is comprised of a strut-and-lattice structure with a bone graft chamber access lid designed to allow the surgeon to deliver a large amount of tightly packed graft inside the interbody structure, maximizing the amount of graft material available for fusion. Furthermore, when the access lid to the graft chamber is closed, the lid is designed to help distribute the loads of the spine in order to reduce the incidence of subsidence by having more surface area available for load distribution.

 With the FDA clearance and upcoming release of the novel Lucent 3D system, Spinal Elements continues its long tradition of excellence and leadership in introducing novel design and materials science to interbody devices.  Spinal Elements was among the first companies to obtain interbody clearance for PEEK devices in 2005 and followed that in 2012 by being the first to apply Ti-Bond®, Spinal Elements’ brand of plasma-sprayed titanium, on the surface of its PEEK interbody devices.

“The FDA clearance of Lucent 3D allows Spinal Elements to differentiate itself in a crowded 3D-printed interbody market.  Lucent 3D’s novel design is meant to address the challenges surgeons have shared with us of other 3D-printed interbody devices – subsidence and the amount of bone graft material available for fusion,” stated President and CEO Jason Blain.  “We are thrilled to obtain this first clearance and look forward to building on this platform to complement our various procedural solutions.”

Spinal Elements is a technology-driven company headquartered in Carlsbad, California. A leading designer, developer, manufacturer and marketer of innovative medical devices used in spinal surgical procedures, Spinal Elements combines leading medical device technologies, biologics and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. Spinal Elements has built a reputation delivering innovative and differentiated technologies that enable fundamental shifts in solutions for spine surgery. The company markets a complete portfolio of advanced spinal implant technologies.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The Evolut ™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access
The study was an analysis of AstraZeneca’s Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF). The patient data from the trial was processed with Brainomix’s e-Lung tool. The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
“Since the algorithm for matching patients with donors is changing across for all organs, this was a prime time to better understand whether transplant team decisions to accept a donated organ varied by patient race and gender,” she said. “We wanted to understand how the process of receiving a transplant after listing varied by race and gender, and the combination of the two, so that steps can be taken to make that process more equitable," said Khadijah Breathett, MD.
The Mount Sinai study found that primary care physicians’ approach reflects a dearth of evidence-based guidance for lung cancer screening shared decision-making in patients with complex comorbidities
This is the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

By using this website you agree to accept Medical Device News Magazine Privacy Policy

Exit mobile version