Spinal Simplicity announces FDA 510(k) Clearance of its Sacroiliac Joint System, the Patriot-SI Posterior Implant, With a Unique Hybrid Indication for Use

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OVERLAND PARK, Kan., May 1, 2024 /PRNewswire-PRWeb/ -- Today, Spinal Simplicity is pleased to announce the Food and Drug Administration (FDA) 510(k) clearance of the Patriot-SI Posterior Implant System as part of a hybrid SI joint fusion construct to be used in conjunction with the Liberty-SI lateral transfixing system. The Patriot-SI Posterior Implant System is intended 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 (i.e., a "transfixing" device) implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct.

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Provider: 
PR NewswirePR Newswire
Retrieved on: 
Wednesday, May 1, 2024
Information
Tags: 
FDA, Sacrum, Food, Ilium, Arthralgia, Simplicity, Titanium, Patient, Physician, Synovial joint, Liberty, Sacroiliac joint, Patriot, Medical device
Geotags: 
KANSAS, PARK, SI, KS
Organisation: 
SPINAL SIMPLICITY
Summary
Key Points: 
  • Spinal Simplicity announced the FDA 510(k) clearance of its Patriot-SI Posterior Implant System, designed for sacroiliac 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.
  • The Patriot-SI Posterior Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac disruptions and degenerative sacroiliitis.
  • "This announcement today marks a second product milestone in the past five months for Spinal Simplicity," said CEO Todd Moseley .




Spinal Simplicity announces FDA 510(k) Clearance of its Sacroiliac Joint System, the Patriot-SI Posterior Implant, With a Unique Hybrid Indication for Use

Spinal Simplicity announced the FDA 510(k) clearance of its Patriot-SI Posterior Implant System, designed for sacroiliac 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.

OVERLAND PARK, Kan., May 1, 2024 /PRNewswire-PRWeb/ -- Today, Spinal Simplicity is pleased to announce the Food and Drug Administration (FDA) 510(k) clearance of the Patriot-SI Posterior Implant System as part of a hybrid SI joint fusion construct to be used in conjunction with the Liberty-SI lateral transfixing system. The Patriot-SI Posterior Implant System is intended 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 (i.e., a "transfixing" device) implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct.

"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," said CEO Todd Moseley.

"This announcement today marks a second product milestone in the past five months for Spinal Simplicity," said CEO Todd Moseley. "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," added CEO Todd Moseley.

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.

"Today 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, KS. "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 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 ensures robust decortication of the bone to prepare the joint for fusion.

"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, OK. "Spinal Simplicity continues to innovate and 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 Q2 of 2024, with a full market release in Q3 of 2024.

For further information or media inquiries, please contact Parker Snedden, Senior Director of Marketing, at [email protected].

About Spinal Simplicity

Spinal Simplicity, LLC, headquartered in Overland Park, Kansas, was founded in 2008 with a vision to be the global leader in innovation, simplified surgical solutions, delivering uncompromising quality. The company has successfully been awarded 150+ patents with additional patent applications pending. For more information visit spinalsimplicity.com or follow us on LinkedIn.

Media Contact

Parker Snedden, Spinal Simplicity, 1 (913) 451-4414, [email protected], https://spinalsimplicity.com

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SOURCE Spinal Simplicity



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