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.
Features unique to the product include a large footprint that helps to reliably seat the guide on the bone anatomy, improved visibility to alignment, and a corrugated design on the cutting slots that aid surgical irrigation. This is complemented by soft tissue offsets which are designed to preserve the periosteum, the outer fibrous layer of the bone which aids in its healing and recovery.
3D Systems has manufactured more than 1 million medical device implants and supports 85+ CE-marked and FDA-cleared products. The company's VSP surgical planning products include a service-based approach to personalized surgery, and utilize expertise in medical image processing, surgical planning and 3D printing. The company has more than 10 years of expertise in craniomaxillofacial applications, and, to date, has worked with surgeons to plan and guide more than 140,000 patient-specific procedures.