3D printing has been playing a big role in helping people with spinal conditions over the last few years, particularly in terms of implants and other medical devices. But none of these 3D printed spinal solutions can get too far without the necessary clearance from the FDA. Florida-based Captiva Spine, Inc., a privately owned medical device organization that was founded in 2007, recently received 510(k) clearance from the FDA for its 3D printed TirboLOX-L Titanium Lumbar Cages.
“With the advanced capabilities of 3D Additive Manufacturing we were 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 ingrowth and vascularization,” said Dennis Ty, the Director of R&D of Captiva Spine. “Through substantial surgeon design input we are able to deliver TirboLOX-L’s unique dual layer organic lattice structure with numerous geometries and sizes that appeal to a wide range of surgeon preferences.”
The company helps spine surgeons, healthcare facilities, and tenured spine distributors that work to provide patients with progressive, high quality spinal care. It’s dedicated to providing elegant and intuitive spinal fusion solutions, such as its TirboLOX-L Titanium Lumbar Cages. This spinal implant uses 3D printing to form interbody fusion devices, made out of titanium alloy, with a double layer organic lattice structure.
The lattice structure has an open architecture, a micro-rough surface topography, and interconnected dual porosity. The architecture can help lower radiographic presence to ensure clear imaging, while implants that possess the latter two features have shown that they can promote bone ingrowth, ongrowth, and vascularization. In addition, Captiva’s TirboLOX-L has a high coefficient of friction, which, as the company puts it, “creates immediate bidirectional fixation.”
Some of the main benefits of 3D printed porous titanium alloy cages, like the TirboLOX-L lumbar cages made of Titanium Alloy (Ti-6Al-4V), is bone’s ability to successfully grow within its architecture, which can then help it achieve good kinematic properties. The TirboLOX-L Titanium Lumbar Cage also features the company’s Pivotec technology.
“I am pleased our development team was able to incorporate our proprietary Pivotec Pivoting TLIF Cage into TirboLOX,” said Dale Mitchell, the President and Founder of Captiva Spine. “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.”
With FDA clearance, Captiva is now cleared to take its 3D printed TirboLOX-L Titanium Lumbar Cage to market. This device is also one of five new product launches that the company is featuring at the upcoming North American Spine Society (NASS) Annual Meeting later this month in Los Angeles. Stop by its booth #1649 at the meeting to see the other four.
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