SurGenTec Adds Navigation Option to FDA-Cleared SI Joint Fusion System

The FDA cleared SurGenTec’s navigation instruments for use with its TiLink SI Joint Fusion system, adding real-time guidance for minimally invasive procedures in patients with persistent SI joint pain.

The FDA has cleared SurGenTec’s TiLink navigation instruments for use with the TiLink SI Joint Fusion system in sacroiliac, or SI, joint procedures. The newly cleared instruments are built to work with Medtronic’s StealthStation navigation platform, adding real-time guidance during minimally invasive SI joint fusion surgery.

SI joint procedures can be technically challenging. The SI joint sits where the spine meets the pelvis, and when it becomes painful or unstable, it can cause persistent low back, buttock or pelvic pain. 

The clearance expands SurGenTec’s SI joint portfolio. 

For patients whose symptoms do not improve with non-surgical treatment, fusion may be used to stabilize the joint. SurGenTec said the new navigation instruments are meant to help surgeons more accurately find, access and prepare the SI joint during those procedures.

When used with StealthStation, the instruments provide real-time navigation during placement of the TiLink SI Joint Fusion system, according to the company. SurGenTec said this may help surgeons see complex pelvic anatomy more clearly and place implants with greater precision during minimally invasive procedures.

The TiLink implant uses the company’s Nanotex nano-surface technology and a compression-based design. The implant is intended to help hold the joint steady while also creating a surface that may encourage bone to grow onto and into the implant over time. SurGenTec said that the process could help support fusion and long-term stability.

SurGenTec pointed to preclinical sheep studies showing bone growth on and into the implant surface.

The company also said navigation-assisted approaches are becoming more common in minimally invasive SI joint procedures because they can improve visualization and procedural confidence. 

In the release, Dr. Joshua Abrams, an orthopedic spine surgeon at the Desert Institute for Spine Care in Phoenix, said the navigated system may help improve control and efficiency during SI joint fusion and may be especially useful in patients with SI joint dysfunction who have not responded to conservative treatment.

How Is the SI Joint Fusion Space Evolving?

SI joint fusion has seen several recent developments across implants, launches and clinical studies. In July 2025, Wenzel Spine said it received FDA clearance for panaSIa, which the company described as the first expandable SI fusion implant cleared by the FDA.

In January 2026, Omnia Medical announced the commercial launch of its FDA-cleared PsiF DNA system, a posterior minimally invasive SI joint fusion system intended for conditions including degenerative sacroiliitis and SI joint disruptions. That same month, CornerLoc shared 6-month interim results from a study of its TransLoc 3D system, saying patients showed improvements in pain and function, with no device- or procedure-related adverse events reported during that follow-up period.

4WEB Medical’s SI Joint Truss system was also FDA-cleared, adding another newly cleared device to the space.

Genesys Spine has also reported prospective multicenter study results for its SIros lateral SI joint fusion system, describing improvements in pain, function and radiographic fusion. In March, the company also announced the launch of SIros-X for SI joint fusion and pelvic fixation, with its first case performed in late March.