3D Systems Receives FDA Clearance for Vantage Ankle PSI

Exactech Vantage Ankle PSI

3D Systems gained FDA 510(k) clearance for Vantage® Ankle PSI patient-specific total ankle surgical planning and 3D-printed instruments. The product includes pre-surgical planning and a 3D-printed instrument set that guides resections in the tibia and talus for total ankle replacement surgery using Exactech’s Vantage Total Ankle.

Vantage Ankle PSI 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. 3D Systems and Exactech have entered into a distribution agreement for Vantage Ankle PSI. The system is in pilot launch, with full market availability expected in late 2021.

“3D Systems was founded on a spirit of innovation, and we are constantly looking for opportunities to expand the applications that can be addressed with our VSP® surgical planning solutions to benefit the medical community,” said Menno Ellis, EVP, healthcare solutions, 3D Systems. “Through our collaboration with Exactech, we drew upon our collective expertise in orthopaedics to develop an end-to-end solution for total ankle replacements that is unique to the market. The combination of pre-surgical planning and 3D-printed, patient-specific instruments allows the surgeon to visualize the patient anatomy and surgical approach in three dimensions, and then perform the surgery more efficiently with improved surgical outcomes.”

3D Systems VSP surgical planning solutions include a service-based approach to personalized surgery, combining expertise in medical image processing, surgical planning and 3D printing. The company has a long history in surgical planning with more than 10 years of expertise in craniomaxillofacial applications. To date, 3D Systems has worked with surgeons to plan and guide more than 140,000 patient-specific procedures.