Stryker: Pangea Systems including Femur,Tibia gets 510k clearance from the FDA

Stryker announced that its Pangea Systems including Femur, Fibula, Tibia, Humerus and Utility have received 510k clearance from the U.S. Food & Drug Administration. “FDA clearance is a critical milestone for our Pangea Systems,” said Eric Tamweber, Vice President and General Manager, Stryker’s Trauma business unit. “With these new systems, we are now offering surgeons a comprehensive portfolio that supports a wide range of their trauma needs.” Designed by the collaborative efforts of world-renowned orthopaedic surgeons, the Pangea plates offer an evidence-based design for implant fit. The system was designed to enhance plate fit and screw placement while elevating the plating market through anatomically contoured implants in patient populations with a wide variety of fracture patterns. The intuitive and streamlined instrumentation and implant trays will include 20 anatomic plates and 13 utility plates all accessible in one platform.