Captiva Spine has announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its TirboLOX-L 3D printed Titanium lumbar cages.
TirboLOX-L titanium lumbar cages are created using advanced 3D printing technologies to form titanium alloy interbody fusion devices with a dual layer organic lattice structure. This lattice structure 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 vascularisation. TirboLOX-L’s open architecture is designed to reduce radiographic presence for clear imaging, and its high friction coefficient creates immediate bidirectional fixation, a company press release states.
Dennis Ty, director of research and development at Captiva Spine, comments, “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 in-growth and vascularisation. 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.”
TirboLOX-L incorporates the company’s proprietary Pivotec pivoting TLIF (Transforaminal Lumbar Interbody Fusion) cage. Pivotec has been used in thousands of surgeries to address the challenges of controlling cage insertion and angle manipulation during surgery, according to Captiva Spine president and founder Dale Mitchell. Pivotec technology is now is now available in a wide range of porous titanium 3D printed, sterile packed implants. “This is especially important during minimally invasive (MIS) applications where time and safety is always of the essence,” Mitchell explains.
Captiva’s TirboLOX-L titanium lumbar cages are one of five new product launches that will be featured at Booth 1649 during the North American Spine Society (NASS) meeting (26–28 September, Los Angeles, USA).