Sam Brusco, Associate Editor09.12.23
Stryker has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pangea systems, which include applications for Femur, Fibula, Tibia, Humerus and Utility.
The company said the Pangea systems were designed through collaborative efforts of world-renowned orthopedic surgeons, and that the plates have an evidence-based design for implant fit. Pangea was engineered to enhance plate fit and screw placement as well as bolster the plating market with anatomically contoured implants in patients with a variety of fracture patterns.
Stryker said the instrumentation and implant trays will include 20 anatomic plates and 13 utility plates that are all accessible in one platform.
“FDA clearance is a critical milestone for our Pangea Systems,” Eric Tamweber, VP and GM of Stryker’s Trauma business told the press. “With these new systems, we are now offering surgeons a comprehensive portfolio that supports a wide range of their trauma needs.”
The company said the Pangea systems will be featured at this year’s Orthopaedic Trauma Association meeting and that attendees can learn more about the portfolio and speak with product experts at the event.
The company said the Pangea systems were designed through collaborative efforts of world-renowned orthopedic surgeons, and that the plates have an evidence-based design for implant fit. Pangea was engineered to enhance plate fit and screw placement as well as bolster the plating market with anatomically contoured implants in patients with a variety of fracture patterns.
Stryker said the instrumentation and implant trays will include 20 anatomic plates and 13 utility plates that are all accessible in one platform.
“FDA clearance is a critical milestone for our Pangea Systems,” Eric Tamweber, VP and GM of Stryker’s Trauma business told the press. “With these new systems, we are now offering surgeons a comprehensive portfolio that supports a wide range of their trauma needs.”
The company said the Pangea systems will be featured at this year’s Orthopaedic Trauma Association meeting and that attendees can learn more about the portfolio and speak with product experts at the event.
