FDA Approves 3D-Printed Instruments for Total Ankle Replacement
ROCK HILL, SC–The FDA has provided 510(k) clearance for the Vantage Ankle PSI, a patient-specific, 3D-printed instrument set used during ankle replacement surgery. Vantage Ankle PSI increases operating room efficiency, reliability and improves soft-tissue preservation around the joint. This innovation is a result of the collaboration between 3D Systems and Exactech, which develops and produces implants, instrumentation, and computer-assisted technologies for joint replacement surgery.
Patient-specific orthopedic instruments are an enabling technology that help surgeons prepare the skeletal anatomy to receive an implant. Vantage Ankle PSI, the only product to facilitate direct patient-specific osteotomies in the ankle, is designed to increase surgical efficiency by allowing the surgeon to reduce the number of steps required to prepare the anatomy with a patient-matched 3D-printed instrument set.