VGI Medical, LLC Announces FDA Clearance of the Novel 3D Printed SiJoin® T3 Implant System, for Sacroiliac Joint Transfixation

VGI Medical, LLC announces it has received 510(k) clearance from the United States Food and Drug Administration to market the transfixing SiJoin®  Triangular Trabecular Titanium (T3) Implant System. The SiJoin®  T3 System is the next evolution of the successful SiJoin®  Direct Posterior Fusion Device, proven for over 10 years. VGI's superior engineering and testing has allowed them to design a titanium alloy implant for use in alleviating sacroiliac joint pain and create a simplified process for the surgeon.

LARGO, Fla., April 18, 2023 /PRNewswire-PRWeb/ -- VGI Medical, LLC announces the new US FDA 510(k) cleared SiJoin®  Triangular Trabecular Titanium (T3) Implant System. The transfixing SiJoin®  T3 Implant is made from Ti-6AI-4V ELI titanium alloy using an additive manufacturing process, where the trabecular construction is engineered to mimic cancellous bone structure. The SiJoin®  T3 Implant is engineered with a dual geometric shape designed to be implanted within the plane of the SI joint, simultaneously positioned within the cortical walls of the ilium and sacrum, providing high surface area contact for transfixation. The implant is held against rotation via the stabilizer fins positioned between the opposing ilium and sacrum surfaces, and the non-circular cross-section of the main body. The novel design of the SiJoin®  T3 Implant fixes the ilium and sacrum relative to one another, maintaining the anatomical spacing of the SI joint, providing mechanical support by transfixing the SI joint while biologic fusion occurs.

The SiJoin®  T3 System uses a less destructive posterior approach to achieve transfixation, in which two small incisions may be used to access the SI joint. Specialized SiJoin®  directional instrumentation deploys the implant into the SI joint, positioned across the joint, within the ilium and sacrum for transfixing of the SI joint. Biomechanical performance testing conducted by Dr. Goel at The University of Toledo demonstrates improved performance to lateral systems by taking advantage of the ?leverage arm? concept. Benefits for the surgeon include small incisions and specialized instruments requiring less operating room time and faster patient recovery. The benefit to the patient is less surgical trauma and less pain. Tov Vestgaarden, Ph.D., President and CEO of VGI Medical stated, ?VGI has been in the SI fusion market for over 10 years with a patented procedure and patented product that is proven to help patients increase their quality of life. We are excited to provide an advancement of this existing technology by incorporating the benefits of a 3D printed titanium implant?.

Pull Quote

Biomechanical performance testing conducted by Dr. Goel at The University of Toledo demonstrates improved performance to lateral systems by taking advantage of the ?leverage arm? concept.

Media Contact

Tov Vestgaarden, VGI Medical, LLC, 1 7275651235, [email protected], www.vgimedical.com

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SOURCE VGI Medical, LLC