The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to a novel sacroiliac joint system—brand named Liberty-SI Lateral Implant System, manufactured by Overland Park, Kansas-based Spinal Simplicity, LLC.
According to the 510(k) summary document, the device is “a minimally invasive sacroiliac joint fusion implant that is intended for implantation across the joint space (i.e., the implant transfixes the SI joint).”
The new SI joint implant is “composed of Ti-6AI-4V ELI titanium alloy per ASTM F136 and is partially coated with hydroxyapatite (HA).”
Additionally, to accommodate varying patient anatomy, the implants are “available in multiple diameters and length offerings,” and consist of a “cannulated central threaded body that has deployable Wings and a Compressive Body.”
While “using the designated instrument system, one or two implants may be inserted across the SI Joint to apply a compressive force across the joint and to provide stabilization and fusion.”
The indication is “sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.”
In order to qualify for the shorter and earlier 510(k) clearance the device must be substantially equivalent to a predicate device. The predicate device is the SI-LOK® Sacroiliac Joint Fixation System. The devices have the same indications for use.
The folks at Spinal Simplicity are planning to bring Liberty-SI to market in a focused, soft market launch early in the first quarter of 2024 and unveil the full market release in the second quarter of 2024.
Neurosurgeon Larry Khoo, M.D. said of the announcement, “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.”
Dr. Khoo continued, “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.”
