Captiva Spine's TirboLOX-L™ Dual Layer Organic Lattice Structure 3D Printed Titanium Lumbar Cages Receive Clearance

Wednesday, September 5, 2018 General News
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Captiva Spine is announcing it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its TirboLOX-L 3D Printed Titanium Lumbar Cages.

JUPITER, Fla., Sept. 5, 2018 /PRNewswire-PRWeb/ -- Captiva Spine is a medical device organization located in Jupiter,

Florida, dedicated to delivering smart, elegant and intuitive spinal fusion solutions. Today, Captiva Spine is announcing it has received 510(k) clearance from the U.S. 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 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, Director of R&D of Captiva Spine declared, "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 vascularization. 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."

Dale Mitchell, President and Founder of Captiva Spine said, "I am pleased our development team was able to incorporate our proprietary Pivotec® Pivoting TLIF Cage into TirboLOX-L. 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."

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 held 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. Captiva Spine can be contacted directly by phone at 561-277-9480 or via their website http://www.captivaspine.com/contact-us.

About Captiva Spine, Inc. Captiva Spine is a privately owned medical device organization founded in 2007. Captiva Spine supports spine surgeons, tenured spine distributors, and healthcare facilities in providing patients with progressive spinal care and an obsessive focus on quality. They strive to create and maintain sincere, honest, collaborative relationships. By valuing their relationships above all else, it fosters the mutual trust and openness needed for Captiva Spine to be a conduit of high quality, smart, elegant, and intuitive patient solutions. Captiva Spine operates as a family of industry professionals that take pride in delivering these solutions responsibly and ethically while never losing sight of what they refer to as the Human Factor: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm.

 

SOURCE Captiva Spine, Inc.



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