Stryker’s Pangea Systems Received 510k Clearance From U.S. Food & Drug Administration
Wednesday, September 13, 2023
Stryker (NYSE: SYK), a leading global medical technology company, has announced that its Pangea Systems, including components such as Femur, Fibula, Tibia, Humerus, and Utility, have received 510k clearance from the U.S. Food & Drug Administration.
Eric Tamweber, Vice President and General Manager of Stryker's Trauma business unit, emphasized the significance of FDA clearance for the Pangea Systems, stating, "FDA clearance is a pivotal milestone for our Pangea Systems. With these new systems, we are now offering surgeons a comprehensive portfolio to support a wide range of trauma-related needs."
The development of these Pangea plates involved collaboration with renowned orthopedic surgeons, ensuring a design grounded in evidence for optimal implant fit. The system's primary goal is to enhance plate fit and screw placement, setting new benchmarks in the plating market by providing anatomically contoured implants tailored to address a variety of fracture patterns across diverse patient populations. The instrumentation and implant trays are designed to be intuitive and streamlined, encompassing 20 anatomic plates and 13 utility plates, all accessible within a single platform.
The Pangea Systems will be showcased at the Annual Orthopaedic Trauma Association meeting in Seattle from October 18-21 (booth #505), offering attendees an opportunity to explore the portfolio and engage with product experts for further information.