HKT Anatomical Locking Trauma System

The HKT Anatomical Locking Trauma System is a collection of implantable bone plates, bone screws, and washers intended for adult patients to fixate fractures, osteotomies, and non-unions of the clavicle, humerus, elbow, radius, ulna, hand, tibia, and foot. It is a metallic bone fixation appliance used in orthopedic trauma surgery.

The subject device and predicate devices have the same intended use, similar indications, technical characteristics, and principles of operation. Despite minor differences in sizes, the devices range in similar shapes and configurations. Both devices have equivalent mechanical performance based on testing.

Biocompatibility testing per ISO 10993 series (cytotoxicity, sensitization, irritation, acute/subchronic systemic toxicity, pyrogenicity, genotoxicity). Performance testing per ASTM F382 (Metallic Bone Plates) and ASTM F543 (Metallic Medical Bone Screws).

The HKT Anatomical Locking Trauma System is substantially equivalent to its predicate device (K231213) because both devices have the same intended use, similar mechanical specifications, and equivalent mechanical performance. Mechanical testing on worst-case subject devices demonstrated performance meeting applicable standards and matching the predicate device's properties.