Medical Device News Magazine

Friday, March 31, 2023

Research Park at Florida Atlantic UniversityR Based FloSpine Receives FDA Clearance for 3D Printed Titanium Cervical Implant

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 GrowFLFlorida 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.

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