510(k) Clearance for Cannulated, Guidewire SI Joint System

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to a novel, cannulated, guidewire directed sacroiliac joint (SI) fusion implant to Overland Park, Kansas-based firm, Spinal Simplicity, LLC.

This new SI joint system is brand named: Patriot-SI Posterior Implant System. It is to be used in conjunction with the Liberty-SI lateral transfixing system.

According to the 510(k) summary document, the system is a “minimally invasive sacroiliac joint fusion implant that is intended for implantation on a trajectory in line with the joint space.” It is offered in one size and “may be implanted using the designated surgical instruments through a posterior approach into the SI joint space, fixating on both the sacrum and ilium via external threads.”

The implant system is “intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.” When the system is implanted, it must be used with a transfixing device “implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct for the purpose of stabilizing and fusing the sacroiliac joint.”

Spinal Simplicity CEO Todd Moseley told OTW, “This announcement today marks a second product milestone in the past five months for Spinal Simplicity.”

Moseley continued, “We’ve already seen excellent patient outcomes with the Liberty-SI Lateral System since its introduction in December 2023. The Patriot-SI technology is constructed intentionally as a cannulated implant, designed for repeatable, reproducible techniques, with the implant traveling directly over the guidewire for precision placement in the SI Joint.”

In addition to the 510(k) clearance, Spinal Simplicity also has patent protection for the device. According to the company, the patent teaches a “novel Patriot-SI cannulated and threaded device, which includes an internal lattice structure to promote fusion.” The cannulated design is “the only posterior SI device that allows continuous control while being delivered over a guidewire.”

Spinal Simplicity submitted the device for 510(k) clearance. Spinal Simplicity is a medical device company focused on developing solutions to treat complex spine conditions.

In order to qualify for 510(k) clearance a device must be substantially equivalent to a predicate device. Here, the implant system has the same indications for use as the predicate device. The predicate device is Ilion Medical Inc.’s NADIA SI Fusion System.