CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System

The CarboClear® Posterior Cervical Screw System and CarboClear® Hybrid Posterior Cervical Screw System are spinal fixation devices designed to stabilize and immobilize cervical and upper thoracic spine segments. They are used as adjuncts to fusion for treating traumatic fractures, degenerative disease, instability, failed previous fusions, and spinal infections, and can also restore spinal column integrity in advanced cancer patients without fusion when life expectancy is limited.

The devices use carbon fiber-reinforced polyetheretherketone (CFR-PEEK) screws with titanium shells and optional tantalum markers. The Hybrid variant incorporates titanium alloy tulips and titanium alloy set screws, while the standard version uses CFR-PEEK set screws. Both systems include CFR-PEEK rods with optional titanium alloy rods, supplied sterile for single use.

ASTM F1717 (static and dynamic compression bending tests), ASTM F1798 (flexion-extension and axial and torsional gripping capacity), and wear evaluation testing.

The intended use, design, dimensions, materials, technological characteristics, principles of operation, and performance of both systems are substantially equivalent to their predicate devices (CMORE® CT System, prior CarboClear® Posterior Cervical Screw System, INFINITY™ OCT System, and CarboClear® Hybrid Pedicle Screw System), as demonstrated by comparable test results.