FDA Clears SurGenTec's TiLink-L, Marking a Milestone in Advanced Sacroiliac Joint Fusion Offerings
Friday, June 09, 2023
SurGenTec, a leading company in medical device innovation, proudly announces that its TiLink-L Sacroiliac Joint Fusion System has received clearance from the U.S. Food and Drug Administration (FDA). This advanced implant is the first offering in SurGenTec's portfolio of sacroiliac joint fusion solutions.
The TiLink-L implant sets itself apart with its unique features. It allows for implantation from both lateral and posterior/oblique approaches and incorporates specialized surface technology that optimizes bone growth. Its design enables superior compression across the joint, providing patients with an excellent fusion platform. The implant is also equipped with SurGenTec's proprietary Nanotex® surface technology, which has demonstrated bony in-growth and on-growth in in-vivo studies, potentially improving stability and surgical outcomes. Additionally, the implant includes a helical self-harvesting channel to promote healing by utilizing the patient's own bone, as well as strategically placed graft windows to facilitate fusion through the screw and enhance stability. The TiLink-L system offers a comprehensive range of implant lengths to ensure a custom fit, optimal fixation, and reduced complications for patients.
SurGenTec's introduction of the TiLink-L implant comes at a time of significant growth in the sacroiliac joint fusion market. As the population ages and the demand for minimally invasive surgical solutions increases, SurGenTec's innovative implant is positioned to address this emerging need effectively.
Travis Greenhalgh, CEO of SurGenTec, expresses enthusiasm regarding the FDA clearance: "We are thrilled to announce the FDA clearance of our first treatment option in our sacroiliac family of products. TiLink-L's unique properties and its ability to adapt to diverse patient needs make it an excellent choice for stabilizing the sacroiliac joint using different approaches. Whether in an outpatient or hospital setting, we believe this device will significantly impact patient care."