Indiana-based Nexxt Spine, LLC. received good news in May with the 510(k) clearance of two new interbody fusion devices for anterior and lateral fusion surgery. The Nexxt Spine ALIF (anterior lumbar interbody fusion) and Lateral systems received clearance on May 21, 2020 and will be available later this summer.
FDA Clears Two New Devices From Nexxt Spine for Lumbar Fusion
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The interbody devices are made from Nexxt Spine’s Nexxt Matrixx® 3D printed titanium. The 3D printing process allows for customization of several key material characteristics. The process generates pore sizes that are ideal for osseointegration, a customized modulus of elasticity lower than PEEK to reduce the risk of subsidence, and a roughened surface shown to induce osteoblast differentiation and expansion.
In a press release posted to the company’s website company President Andy Elsbury said they are “thrilled to be releasing these two powerhouses this year.” He added, “Our engineering and 3D printing manufacturing teams has [sic] been working diligently to simultaneously develop and clear the two products after considerable surgeon demand for Nexxt Spine quality clinical outcomes for ALIF and Lateral approaches.”
An alpha launch of Nexxt Spine ALIF is expected for August 2020, with the Lateral system following in September 2020. An integrated plate system is planned for release in Q4 of this year. The anterior and lateral lumbar systems expand the company’s portfolio of 3D printed titanium implants that currently includes stand-alone and standard cervical spacers, vertebral body replacement for corpectomy, and TLIF and oblique TLIF cages for lumbar fusion. The company also offers a full line of fixation devices and PEEK interbody cages. Nexxt Spine designs and manufactures all of their implants in-house as well as the vast majority of their instruments.
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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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