Frida™ Anterior Cervical Plate System

The Frida™ Anterior Cervical Plate System is an anterior cervical plating system used to stabilize the cervical spine during fusion surgery in skeletally mature patients. It consists of single-use titanium plates and screws, along with manual instruments for implant insertion. The system is indicated for anterior screw fixation as an adjunct to fusion for conditions including degenerative disc disease, spondylolisthesis, spinal stenosis, trauma, failed previous fusions, tumors, curvature deformities, and pseudoarthrosis.

The Frida system has similar technological characteristics, surgical approach, materials, range of sizes, design, and principles of operation as the predicate devices. Plates are manufactured from titanium (Ti-6Al-4V ELI) per ASTM F136 with a graft window for intraoperative visualization. Screws are also titanium (Ti-6Al-4V ELI) per ASTM F136 and available in self-tapping and self-drilling options. The system is available in fixed or variable configurations with a range of sizes to accommodate individual pathology.

Mechanical testing was performed per ASTM F1717, which covers static compression, dynamic compression, and static torsion testing for spinal fixation devices.

The Frida system demonstrates substantial equivalence because mechanical performance testing showed that worst-case constructs were substantially equivalent to legally marketed predicate devices (ZION Anterior Cervical Fixation System, Rex Anterior Cervical Plate System, and C-TEK MAXAN Anterior Cervical Plate System) in the same product class. The device has identical indications for use as the primary predicate and similar indications as additional predicates, uses the same materials and design principles, and performs equivalently under standardized mechanical testing, demonstrating no differences in technological characteristics that would raise different safety or effectiveness questions.