Medical technology giant, Stryker, announces that its Pangea Systems, including Femur, Fibula, Tibia, Humerus, and Utility, have secured 510k clearance from the U.S. Food & Drug Administration. This clearance marks a significant step in offering surgeons a comprehensive trauma care portfolio.
Key Highlights
- Stryker’s Pangea Systems have received 510k clearance from the U.S. FDA.
- Eric Tamweber, Vice President and General Manager of Stryker’s Trauma business unit, emphasized the comprehensive nature of the new systems.
- The Pangea plates, designed in collaboration with top orthopaedic surgeons, aim to enhance implant fit and screw placement.
- The Pangea Systems will be showcased at the Annual Orthopaedic Trauma Association meeting in Seattle from Oct. 18-21.
Source: Business Wire
Notable Quotes
- “FDA clearance is a critical milestone for our Pangea Systems,” – 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.” – Eric Tamweber.
SoH's Take
Stryker’s announcement of the FDA clearance for its Pangea Systems is a testament to the company’s commitment to advancing trauma care. The Pangea plates, designed with input from leading orthopaedic surgeons, promise to offer enhanced implant fit, which is crucial for patient recovery. The upcoming showcase at the Annual Orthopaedic Trauma Association meeting will provide a platform for industry professionals to delve deeper into the system’s capabilities. As Stryker continues to innovate in the medical technology space, its focus on improving patient outcomes remains evident.
