FDA Clearance for Surgical Planning Application

The Food and Drug Administration (FDA) has provided 510(k) clearance for 3D Systems’ Vantage Ankle PSI - its patient-specific total ankle surgical planning and 3D printed instruments. The product includes pre-surgical planning and a patient-specific 3D-printed instrument set that guides resections in the tibia and talus for total ankle replacement surgery using Exactech’s Vantage Total Ankle System. 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 (Gainesville, Florida), a developer and producer of innovative implants, instrumentation, and computer-assisted technologies for joint replacement surgery.

Patient-specific orthopaedic instruments are an enabling technology that help surgeons prepare the skeletal anatomy to receive an implant. The Vantage Ankle PSI product, a solution 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. It features 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.

To date, 3D Systems has worked with surgeons to plan and guide more than 140,000 patient-specific procedures.

3D Systems and Exactech have entered into a distribution agreement for the Vantage Ankle PSI product offered exclusively with Exactech’s Vantage Total Ankle System. The Vantage Ankle PSI is currently in pilot launch with full market availability expected in late 2021.