Spinal Simplicity Gains FDA 510(k) for Patriot-SI Posterior Implant

Spinal Simplicity received FDA 510(k) clearance to market the Patriot-SI Posterior Implant System, designed for sacroiliac (SI) joint fusion in combination with the Liberty-SI lateral system. This clearance introduces a hybrid SI joint fusion construct, offering new treatment options for conditions such as sacroiliac disruptions and degenerative sacroiliitis.

When Patriot-SI is implanted, it must be used with a Spinal Simplicity Liberty-SI Lateral System device implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct.

Spinal Simplicity has been granted patent protection for the novel Patriot-SI cannulated and threaded device, which includes an internal lattice structure to promote fusion. The patented cannulated design is reported to be the only posterior SI device that allows continuous control while being delivered over a guidewire.

Patriot-SI is a minimally invasive SI joint fusion implant intended for implantation on a trajectory in line with the joint space. The additively manufactured titanium implant is available in one size, fixating both the sacrum and ilium via external threads. The procedure also involves the lateral insertion of a small titanium Liberty-SI implant, transfixing the SI joint to stabilize and fuse the joint. This hybrid surgical technique supports robust decortication of the bone to prepare the joint for fusion.

CEO Todd Moseley said, “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.”

Source: Spinal Simplicity