The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to a lumbar facet device which was a 2023 Best Technology in Spine award winner. The manufacturer is SC Medica, and the device brand name is SC Medica FFX®.
The novel facet fixation system is for use in lumbar spinal fusion surgery. According to the FDA’s 510(k) summary document, the device is “placed bilaterally through a posterior surgical approach and spans the facet interspace.” It must be used with “an FDA-cleared transfacet screw cleared for use in the lumbar spine.”
The device is intended to “provide temporary fixation and stabilization to the spine as an aid to lumbar fusion through bilateral immobilization of the facet joints at one or two levels with autogenous and/or allogenic bone graft.”
It must be accompanied by “an FDA-cleared intervertebral body fusion device and/or with an FDA-cleared posterior lumbar pedicle screw and rod system implanted at the same spinal level(s) as an adjunct to a single or two-level intervertebral body or posterolateral fusion, respectively.”
The device is indicated for the “treatment of patients with lumbar degenerative disc disease (DDD) from L3 to S1 in skeletally mature patients who have failed conservative care.”
A device must be substantially equivalent to a predicate device to qualify for shorter and earlier 510(k) clearance. According to the 510(k) summary document the lumbar facet device is substantially equivalent in indications, design principles, and performance to the PMT Facet Fixation System, Lumbar and the SurGenTec Ion Facet Screw System.
SC Medica, a company focused on facet fixation solutions based in Strasbourg, France, submitted the device for 510(k) clearance. The device is the SC Medica FFX®.
OTW spoke with SC Medica CEO and Founder Camille Srour, Ph.D. about the device. He commented, “With over 10,000 implantations to date, the FFX device is currently the most widely used lumbar facet cage on the market. We are thrilled that U.S. patients can now benefit from this unique, minimally invasive technology.”
