Strasbourg, France,May 9, 2024. SC MEDICA, leader in facet fixation solutions, today announced that it has obtainedregulatory clearance from the United States Food and Drug Administration (FDA) for its medical device FFX®, a facet fixation system for use in lumbar spinal fusion surgery. This achievement was supported by compelling clinical evidence comparing FFX® and pedicle screw fixations at 2+ years post-surgery in 112 patients.
This FDA clearance represents a significant milestone in SC MEDICA’s expansion to the $7 billion facet disease and fixation market.
The FFX®system, placed bilaterally through a posterior surgical approach and spanning and compressing the facet joint interspace, is designed to aid lumbar fusion through bilateral immobilization of the facet joints.
“We are immensely proud to receive FDA clearance for our FFX®lumbar facet fixation system.” said Camille Srour, CEO and founder of SC MEDICA.“This achievement underscores our dedication to innovation and our mission to raise awareness about the role of facet joints in a very large number of spinal conditions.”
Camille Srour added, “we are thrilled to now make this technology to benefit US patients, and to become the only spine company to clear our facet devicefrom the L3 to S1 levels, for up to 2 levels,not only in addition to an intervertebral body fusion device but also,alternatively, to pedicle screw systems.”
With 7years of followup in Europe, FFX®has been successfully used in more than 10,000 implantations worldwide to date.
For more information about SC MEDICA’s FFX®device, visit www.sc-medica.com.
About SC MEDICA: SC MEDICA, founded in 2015, is a leading spinal facet fixation company, dedicated to providing innovative solutions for back pain control and spinal fusion. With a commitment to excellence and innovation, SC MEDICA strives to advance standards of care and address unmet patient needs worldwide.