FDA Clears Spinal Simplicity’s Sacroiliac Joint System

Spinal Simplicity has gained U.S. Food and Drug Administration (FDA) 510(k) clearance of its Patriot-SI Posterior Implant System as part of a hybrid SI joint fusion construct intended for use with the Liberty-SI lateral transfixing system.

The Patriot-SI Posterior Implant System is designed specifically for sacroiliac joint fusion for conditions including sacroiliac disruptions and degenerative sacroiliitis. When the Patriot-SI System (i.e., an in-line or intra-articular device) is implanted, it must be used with a Spinal Simplicity Liberty-SI Lateral System device (a transfixing device) implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct.
 
“This announcement marks a second product milestone in the past five months for Spinal Simplicity,” CEO Todd Moseley said. “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.” 
 
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 the only posterior SI device that allows continuous control while being delivered over a guidewire.
 
“[This] marks a milestone for my patients who are hypermobile and may need an advanced construct in their SI Joint along all planes of the joint,” said Dr. Dan Kloster of Crimson Pain Management in Overland Park, Kan. “I now have this option in my toolkit for the right patient to help alleviate their SI Joint pain.”
 
The Patriot-SI is a minimally invasive SI joint fusion solution implanted on a trajectory 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 ensures robust decortication of the bone to prepare the joint for fusion, according to the company.
 
“The FDA clearance of the Patriot-SI posterior system, to be implanted with the Liberty-SI lateral system as a hybrid construct, gives us as physicians another option for our patients based on their underlying cause of SI discomfort,” said Dr. Doug Beall of Oklahoma City, Okla. “Spinal Simplicity is not content with the status quo. This approach certainly helps our patients who are struggling with SI Joint pain and dysfunction.”

Patriot-SI’s anticipated soft market launch is scheduled for late this quarter, with a full market release in the third quarter this year.
 
Headquartered in Overland Park, Kan., Spinal Simplicity was founded in 2008 has been awarded more than 150 patents with additional patent applications pending. The company develops solutions for spine-related conditions.