Stryker (NYSE:SYK) announced today that its Pangea systems — including femur, fibula, tibia, humerus and utility — received FDA 510(k) clearance.
Kalamazoo, Michigan-based Stryker designed its Pangea systems with collaborative efforts from world-renowned orthopedic surgeons. The plates offer an evidence-based design for implant fit.
The company said in a news release that it designed the system to enhance plate fit and screw placement. It also elevates the plating market through anatomically contoured implants in patient populations with a wide variety of fracture patterns. Stryker says its intuitive and streamlined instrumentation and implant trays include 20 anatomic plates and 13 utility plates. The company made them all accessible through just the one platform.
Stryker plans to feature its Pangea systems at the Annual Orthopaedic Trauma Association next month in Seattle.
“FDA clearance is a critical milestone for our Pangea Systems,” said Eric Tamweber, VP and GM of 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.”
