Together with FloSpine, LLC, the Research Park at Florida Atlantic University® is pleased to announce that FloSpine has achieved 510(k) clearance for its first 3D Printed Titanium Ti-Largo™ Cervical Interbody Cage System from the Food and Drug Administration (FDA).
BOCA RATON, Fla. (February 28, 2023) - Together with FloSpine, LLC, the Research Park at Florida Atlantic University® is pleased to announce that FloSpine has achieved 510(k) clearance for its first 3D Printed Titanium Ti-Largo™ Cervical Interbody Cage System from the Food and Drug Administration (FDA).
The Ti-Largo™ Cervical Interbody Cage System is used to support the spine after a cervical collapse or damaged disc has been removed and is replaced with the Ti-Largo implant to restore the height. All Ti-Largo implants utilize titanium additive manufacturing (3D printing) and a patent-pending design to create a highly porous surface structure that allows for bone ingrowth to the implant surfaces, maximizing strength, stability and biologic fixation.
“We are very pleased with the FDA clearance of the Ti-Largo System. 3D printing our spinal implants allows us to create various shapes and sizes to match the patient’s anatomy more accurately”, says Peter Harris, president and CEO of FloSpine.
FloSpine is a spinal implant medical device company, researching and developing innovative and cost-effective solutions for spinal implants and instruments. The company’s goal is to apply new technology and design concepts to solve medical problems of the human spinal column. The company provides surgeons with products resulting in enhanced surgical outcomes, shorter hospital stays, and quicker recovery times, thereby reducing the procedural and rehabilitative costs to the patient and insurer.
The Ti-Largo Cervical Interbody Cage System adds to the existing portfolio of four (4) products designed for complex spine disorders, including scoliosis and degenerative disc disease, all of which are named for locations in Florida, the company’s home.
Adding to the excitement of this new approval, Global Ventures nominated FloSpine as a 2022 GrowFL Florida Companies to Watch honoree, and it was among the select winners celebrated on February 23 at Hard Rock Live at Universal CityWalk in Orlando.
Participating in the Research Park at FAU’s Global Ventures second-stage entrepreneurial support initiative has enabled the company to access highly qualified and motivated graduate students from the FAU College of Engineering and Computer Science who have become full-time employees, access to specialized equipment at Florida Atlantic University and connections to its research faculty.
“FloSpine’s growth and success exemplifies the aims of Global Ventures, and bodes well for its future endeavors,” commented Ryan Lilly, program manager of the Research Park at FAU’s Global Ventures.
About FloSpine, LLC
FloSpine, LLC is a privately held US medical device company offering products for addressing complex deformity spine problems, minimally invasive spine surgery and thoracolumbar degenerative conditions. For more information, please visit FloSpine at http://www.flospine.com. Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward-looking statements.
About the Research Park at Florida Atlantic University®
The Research Park at Florida Atlantic University® is home to technology companies and research-based organizations working to support the research and development activities of Florida Atlantic University and to foster economic development and broaden the economic base of Broward and Palm Beach counties. The Research Park at FAU hosts Global Ventures, an international soft-landing center for second-stage technology companies and FAU Tech Runway, a South Florida public-private partnership that serves as a hub to accelerate technology development and incubate startup companies. The Research Park at FAU is a 70-acre destination for R&D companies to thrive, established in 1985, it is widely regarded as South Florida’s laboratory for new entrepreneurial ideas and technologies. The Research Park at FAU is governed by the Florida Atlantic Research and Development Authority, an independent special district created by Palm Beach and Broward counties in partnership with Florida Atlantic University, organized under Chapter 159, Part V, Florida