HC Biologics Osteopoint Spinal Fixation System

The HC Biologics Osteopoint Spinal Fixation System is a posterior spinal fixation device designed to provide immobilization and stabilization of the thoracic, lumbar, and sacral spine in skeletally mature patients as an adjunct to fusion. It is intended to treat acute and chronic spinal instabilities or deformities including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudoarthrosis, and failed previous fusion.

The device is a top-loading, multiple-component system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated and spondylolisthesis screws, rods (straight and curved), connectors, hooks, and set screws. All components are fabricated from titanium alloy (Ti6Al4V-ELI) conforming to ASTM F136 and are supplied non-sterile for single use in various sizes.

Biomechanical testing of the predicate Mikron Spinal Fixation System (which is identical to the HC Biologics Osteopoint system) is performed according to ASTM F1798, ASTM F2193, and ASTM F1717.

The HC Biologics Osteopoint system is substantially equivalent to the MSFX Mikron Spinal Fixation System (predicate K241657) because it has identical indications for use, the same technological characteristics including materials, design, function, range of sizes, manufacturing processes, surgical techniques, and intended use. Biomechanical testing demonstrates equivalence to established consensus standards, supporting that the devices perform similarly in their intended application.