Tyber Medical Anatomical Plating System

The Tyber Medical Anatomical Plating System is a bone fixation device consisting of metallic plates, screws, washers, and instrumentation. It is intended to bridge or stabilize bone fragments to facilitate healing, with two main systems: the Mini-Frag System for small bones and fragments (hand, wrist, foot, ankle), and the Ankle Fracture/Fusion System for distal tibia and fibula fixation. Both systems are offered non-sterile and are not for spinal use.

The device components are made of Ti-6Al-4V ELI (ASTM F136) with Type II anodized surface treatment for plates, and color anodizing for sizing on screws and washers. The system incorporates plates of various lengths, thicknesses, and configurations, plus standard (non-locking) and locking screws of varying dimensions, optional bone screw washers, specialized trays, and ancillary instrumentation. An MR assessment demonstrated the system is MR Conditional.

ASTM F2052 for magnetically induced displacement force, ASTM F2213 for magnetically induced torque, ASTM F2182 for RF-induced heating, and ASTM F2119 for image artifacts were used in the MR assessment. Engineering analysis was performed comparing the subject devices to predicate devices.

This is a line extension to previously cleared Tyber Medical Anatomical Plating Systems (K232652, K241218, K233423/K222465). The additional plates, screws, washers, and instrumentation have the same indications for use, intended use, and materials as the predicate devices. Engineering analysis demonstrated no new worst-case scenarios are introduced by the added components, and they possess similar technological characteristics to the previously cleared predicate devices.