The TiLink posterior locking screw and compression anchor. Credit: SurGenTec/ Business Wire.

SurGenTec has received clearance from the US Food and Drug Administration (FDA) for its posterior sacroiliac joint fusion system, TiLink-P.

Said to be the first-of-its-kind, the new minimally invasive implant is intended for the treatment of patients with chronic sacroiliac (SI) joint pain.

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It combines compression across the sacroiliac joint with a posterior implantation approach, allowing doctors to stabilise the painful area and offering patients a path to healing.

Unlike current methods, which involve multiple incisions and large bulky implants, the new minimally invasive technology only needs a single small incision and integrated implant.

Furthermore, TiLink-P facilitates the delivery of a substantial quantity of bone graft in and around the implant. It will help improve fusion and surgical outcomes.

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Designed to require no additional hardware support for supporting the procedure, TiLink is approved as a stand-alone device that transfixes the ilium and sacrum.

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The company is presently collaborating with several navigation companies to use platforms that work in line with TiLink.

The 3D-printed titanium implant features Nanotex surface technology along with a trellis system for promoting osteointegration.

SurGenTec CEO Travis Greenhalgh said: “By combining the power of compression across the SI joint with the muscle-sparing posterior approach and the ability to reinforce with bone graft, TiLink offers surgeons a new and efficient way to enhance healing in patients.

“We anticipate that this groundbreaking technology will have a profound impact on patient outcomes and improve the overall quality of care.”

Earlier, the company received approval from the FDA for its Tilink lateral sacroiliac fusion system.