SurGenTec’s TiLink Navigation Instruments for SI Joint Fusion Get FDA OK

SurGenTec has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its TiLink navigation instruments for use with the TiLink SI joint fusion system in sacroiliac (SI) joint procedures.

The system was designed for compatibility with Medtronic’s StealthStation navigation platform in order to boost precision during minimally invasive SI joint fusion surgeries. The milestone grows SurGenTec’s growing arsenal of SI joint solutions and supports its mission to support improved outcomes for patients suffering from debilitating SI joint pain.

The TiLink navigation instruments were engineered to help surgeons accurately locate, access and prepare the sacroiliac joint for fusion. When used with StealthStation, the system allows real-time surgical navigation during implantation of the TiLink SI joint fusion system.

The TiLink implant boasts proprietary Nanotex nano-surface technology and a compression-based design to support bone integration and joint stabilization. Pre-clinical ovine studies showed Nanotex, using advanced nanotopography, promotes bone on-growth and in-growth at the implant interface.

“The TiLink Navigation Instruments introduces a new level of efficiency and control in sacroiliac joint fusion,” said Dr. Joshua Abrams, an orthopedic spine surgeon at the Desert Institute for Spine Care (DISC) in Phoenix, Ariz. “When used with Navigation, it enables highly accurate, minimally invasive implant placement, which may help reduce operative time while enhancing procedural safety and outcomes for patients with SI joint dysfunction who have not responded to conservative treatment.”

In January, the company received FDA clearance for its ION-C facet fixation system. ION-C is part of the company’s posterior cervical platform and has received expanded indications to treat cervical pseudoarthrosis when implanted bilaterally within the facet joints