Caliber Intramedullary Fixation System

The Caliber Intramedullary Fixation System is a titanium alloy intramedullary bone screw used to repair acute fractures, malunions, or nonunions of the clavicle. It is a cannulated, self-drilling and self-tapping screw with distal and proximal threads, ranging from 4.5–5.0 mm in diameter and 50–120 mm in length.

The device features self-tapping threads and cannulation, matching predicate characteristics. It has similar design, dimensions, and materials (titanium alloy) to the cleared predicates. The screw includes a cross-screw receiving hole and screw head.

ASTM F543 (torsion, driving torque, and axial pullout); ASTM F1264 (static and dynamic bending). Testing was performed per FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers.

The Caliber system is substantially equivalent because it shares identical intended use (clavicle fracture repair), similar design and dimensions, identical materials, and equivalent technological characteristics (self-tapping threads, cannulation) with three predicate devices. Non-clinical testing demonstrates equivalent safety and performance to those predicates, and minor wording differences in indications for use are insignificant.