BD - Earth day 2024

FDA Clears Tyber Medical's Distal Radius Plating System for Market Access

Tuesday, December 19, 2023

Tyber Medical, a prominent orthopedic device manufacturer specializing in the development of private label orthopedic implants for trauma, extremity, and spine markets, has successfully obtained FDA 510(k) clearance for its latest product—the Distal Radius Plating System. This cutting-edge system, developed by Tyber Medical, caters to a diverse range of fractures, fusions, non-unions, malunions, or osteotomies affecting the radius, ulna, and hand.

The Distal Radius System by Tyber Medical introduces an innovative approach to addressing one of the most common fractures. Its enhanced ergonomic design not only provides a solution to minimize postoperative concerns such as flexor tendon irritation but also ensures stability and orientation in the anteroposterior plane. This is achieved through a dynamic range of plate length options, available in both titanium and stainless steel.

Notably, the design is strategically kept below the watershed line, ensuring minimal prominence while still effectively reaching the radial styloid without the need for an additional locking head size. The system also addresses the demand for narrow volar plates, further enhancing its versatility. Tyber Medical's Distal Radius Plating System sets a new benchmark in orthopedic solutions with its comprehensive features and advancements.