On September 5, 2018, Jupiter, Florida-based Captiva Spine, Inc. announced FDA 510(k) clearance of its TirboLOX-L 3D Printed Titanium Lumbar Cages. The FDA cleared the device within four months of submission.
3D Printed Cage With “Unique Lattice Structure” Cleared
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The company incorporated its proprietary Pivotec technology into the cages. The technology has been used in thousands of surgeries, according to the company.
The cages are created using advanced 3D printing technologies to form titanium alloy interbody fusion devices with a dual layer organic lattice structure.
Lattice Structure
“This lattice structure,” says the company, “features a micro-rough surface topography, interconnected dual porosity, and open architecture. Titanium alloy implants with micro-rough surface topographies and dual porosity have been shown to promote direct bony on growth, in growth and vascularization. TirboLOX-L’s open architecture is designed to reduce radiographic presence for clear imaging. TirboLOX-L’s high coefficient of friction creates immediate bidirectional fixation.”
Dennis Ty, the company’s R&D director, said the engineering team was able to create “a unique lattice structure similar to trabecular bone incorporating a micro-rough surface for clot retention and early osteogenic cell migration, including a dual layer of porosity with pore sizes specifically designed to promote bone in-growth and vascularization.”
Dale Mitchell, the company’s president and founder, said the Pivotec technology has been used in thousands of surgeries “to address the challenges of controlling cage insertion and angle manipulation during surgery and is now available in a wide range of porous Titanium 3D printed, sterile packaged implants. This is especially important during minimally invasive (MIS) applications where time and safety is always of the essence.”
The company said the cages are one of five new product launches that will be featured at Booth 1649 during the upcoming North American Spine Society (NASS) meeting in Los Angeles, September 26-28, 2018. “Inquiries from tenured distribution professionals looking to partner with a company to build a relationship for the long run are always welcome,” said the company.
Cartiva Spine was founded in 2007 and is privately owned.
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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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