Spinal Simplicity announces 510(K) FDA Clearance of its novel Sacroiliac Joint System, the Liberty-SI Lateral Implant
Spinal Simplicity is pleased to announce the U.S. Food & Drug Administration (FDA) 510(K) clearance of the Spinal Simplicity Liberty-SI Lateral Implant System; a transfixing, lateral sacroiliac (SI) joint fusion system. The Liberty-SI Lateral Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac disruptions and degenerative sacroiliitis.
“This announcement today is a milestone moment in the history of Spinal Simplicity as the Liberty-SI now represents best in class SI Fusion technology,” said CEO Todd Moseley.
The procedure involves the lateral insertion of 1 or 2 small titanium implants transfixing the SI joint, designed to stabilize and fuse the joint. The lateral surgical technique first decorticates the bone, preparing the joint for fusion.The Liberty-SI implant is designed to achieve arthrodesis of the SI joint using a lateral technique that passes through the ilium across the sacroiliac joint and into the sacrum, thus transfixing the sacroiliac joint.
“As a Spine Surgeon, the clearance of the Liberty-SI Lateral System gives me the option to use one implant on my patients with a safe, lateral trajectory,” said Dr. Larry Khoo, Neurosurgeon UCLA & Hawaii. “This is great for patients with SI joint pain as it could potentially be a procedure where they aren’t under anesthesia as long, and the implant will compress and fuse the joint as well.”
“Today is a great day for patients and physicians, with the FDA clearance of the Liberty-SI Lateral Implant System,” said Dr. Timothy Deer, Chairman American Society of Pain and Neuroscience. “Interventional pain physicians continue to benefit from the innovation of less invasive therapies that are safer for patients. This is another example of new technology where the patient wins.”
The Liberty-SI’s anticipated targeted, soft market launch is early Q1 of 2024, with a full market release in Q2 of 2024.
For further information or media inquiries please contact Parker Snedden, Senior Director of Marketing,