K2M, Inc. based in Leesburg, Virginia, has announced its U.S. launch of the first 3D-printed expandable fusion device that features infinite adjustment within its expandable range to help restore sagittal balance in spine deformity patients.
K2M Launches 3D-Printed Expandable Cage
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According to the company, “Designed with K2M’s Lamellar 3D Titanium Technology, MOJAVE PL 3D incorporates a porous structure in conjunction with rough surfaces, with the goal of allowing for bony integration throughout the endplates.”
“K2M was the first leading spine company to market a 3D-printed titanium interbody device and offers the most comprehensive portfolio of 3D-printed spinal devices on the market.”
“The MOJAVE PL 3D Expandable Interbody System, which received a 510(k) clearance from the U.S. Food & Drug Administration (FDA) in June 2017, is a first-of-its-kind fusion device designed to allow for independent control of the anterior and posterior heights in the lumbar spine.”
“Featuring infinite adjustment within the expansion range, the implant may be locked at any desired height and lordosis to aid in the restoration of sagittal balance.”
“K2M’s Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques. Starting with a titanium powder, the MOJAVE endplates are grown through the selective application of a high-energy laser beam, incorporating complex internal geometries and a rough surface architecture that pre-clinical data have associated with bone growth activity.”
K2M Chief Operating Officer Lane Major told OTW, “Launching the MOJAVE PL 3D Expandable Interbody System in the United States is an important milestone that advances expandable interbody technology for spine surgery. This is the first 3D-printed device with infinite adjustment in its expansion range, which allows surgeons to independently expand the anterior and posterior heights of the cage. Its versatility and easy-to-use instrumentation assists surgeons in restoring sagittal balance.”
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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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