CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System

The CD Horizon™ ModuLeX™ Fenestrated Screw Set and CD Horizon™ ModuLeX™ Spinal System are posterior spinal fixation implants used as adjuncts to fusion for conditions including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, and tumors. The fenestrated screws contain holes allowing bone cement injection for augmented fixation in advanced tumor patients with limited life expectancy.

The subject devices are spinal fixation implants with the same indications, intended use, fundamental scientific technology, materials, and sterilization as predicate devices. The main technological differences are expanded size offerings and addition of nanoLOCK™ Surface Technology (micro- and nano-roughened surface texture at the nanometer level) to the fenestrated screws to improve bone fixation.

ASTM F1798 (static and dynamic flexion-extension testing); ASTM F1717 (static and dynamic compression bending and static torsion testing). The PCCP also includes navigated instruments accuracy analysis and simulated use testing.

The subject fenestrated screw implants are substantially equivalent to four predicate devices (CD Horizon™ Fenestrated Screw Set K232141 and three CD Horizon™ Spinal System clearances) because they have identical indications, intended use, fundamental scientific technology, materials, and sterilization methods. Mechanical testing demonstrates the proposed devices meet the same acceptance criteria as predicates, and the main differences—expanded sizing and nanoLOCK surface technology—do not alter safety or effectiveness.