FDA OKs Tyber Medical’s Proximal Tibia Plating System

Tyber Medical has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Proximal Tibia Plating System for complete and partial articular fractures.
 
Both designs stabilize bone fragments to help repair injuries to the tibia, fibula, and femur. The company said the system was engineered to accommodate surgical preferences, boost procedural efficiency, and enhance plate fit and screw placement.
 
The Proximal Tibia Plating System features variable angle locking and non-locking screws and is anatomically designed to treat a variety of indications.
 
“This innovative addition to the Tyber Medical portfolio aligns to meet the needs of our customers by offering multiple solutions to challenging anatomy,” said David Hannah, Tyber Medical’s chief technology officer. “This comprehensive system offers anatomic plating to support a wide range of trauma needs.”
 
Tyber’s director of regulatory affairs Lisa Boyle added, “With the clearance of the Proximal Tibial Plating System and its sub-categories, Tyber Medical remains unwavering in our commitment to providing cutting edge orthopedic solutions.”
 
Last month, the company received FDA 510(k) clearance for a line extension to its Mini-Frag system. The FDA nod added 1.3 mm screws and plates, and it’s now indicated for fixation of fractures, osteotomies, nonunions, and fusions in the hand, wrist, foot, and ankle.