The OsteoCentric Bone Plate and Screw System

The OsteoCentric Bone Plate and Screw System is a metallic bone fixation device consisting of clavicle plates (in four anatomical configurations) and locking/non-locking screws in multiple diameters. The plates and screws are made from medical-grade stainless steel or titanium and are intended for fixation of fractures, osteotomies, and nonunions across multiple skeletal sites including the clavicle, scapula, humerus, radius, ulna, pelvis, tibia, and fibula, including periarticular and intraarticular fractures.

The subject device is a line extension adding clavicle plates (superior, superior lateral, anterior lateral, and anterior midshaft configurations) and intermediate screw sizes (2.1 mm, 2.4 mm, and 2.7 mm diameter) that fall within the predicate's size range. The plates are anatomically shaped specifically for the clavicle, differing from predicate plate designs. Materials conform to ASTM F138 (stainless steel) and ASTM F136 (titanium) standards.

ASTM F138 for medical-grade stainless steel and ASTM F136 for titanium material specifications are cited. The document references engineering analysis for bending performance testing but does not explicitly cite additional consensus standards or ISO designations.

Engineering analysis demonstrated that the intermediate screw sizes present no new worst-case scenarios and that the subject clavicle plates exhibit similar bending performance (strength and stiffness) to the predicates. Because the indications for use are identical to the predicate devices, the materials and manufacturing processes are established, and functional performance is equivalent, the device is substantially equivalent despite having anatomically-specific clavicle plate geometries.