Strasbourg, France – October 16, 2025 – SC Medica today announced that its FFX® Facet FiXation System has received U.S. Food and Drug Administration (FDA) clearance for standalone use, making it the first and only facet fusion cage approved for lumbar spine surgery without supplemental fixation.
Following its initial FDA clearance in May 2024 as a complementary posterior fixation system, this new indication represents a major milestone in posterior spinal fusion. It enables surgeons to perform facet arthrodesis without pedicle screws or interbody cages in selected patients.
“This new FDA clearance aligns with our 8 years of European experience using FFX® in standalone procedures” said Camille Srour, Ph.D., founder and CEO of SC Medica. “We are proud to now bring this minimally invasive option to U.S. patients, fully consistent with our philosophy of achieving fusion with the Minimum Necessary Volume of Instrumentation.”
With over 11,000 implantations to date, FFX® stabilizes the posterior column through bilateral facet joint immobilization. Its standalone use simplifies the surgical workflow, reduces operative time, and lowers surgical morbidity compared with conventional fixation systems*.
About SC MEDICA
SC MEDICA, founded in 2015, is the leading lumbar facet arthrodesis company dedicated to providing innovative solutions for back-pain control and spinal fusion.With a commitment to excellence and innovation, SC MEDICA aims to raise awareness of the role of facet joints in a large number of spinal conditions. And establish FFX® facet arthrodesis as a new gold standard in posterior stabilization.
* For more information, visit www.sc-medica.com.