3D Systems’ Vantage Ankle PSI Receives 510(k) Clearance

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, a developer and producer of implants, instrumentation, and computer-assisted technologies for joint replacement surgery.
 
Helping Surgeons
 
Patient-specific orthopedic instruments are an enabling technology that help surgeons prepare the skeletal anatomy to receive an implant. The Vantage Ankle PSI product 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.
 
Collaboration with Exactech
 
“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 orthopedics 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 has manufactured more than 1 million medical device implants and supports 85+ CE-marked and FDA-cleared products. 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.
 
“Our collaboration with 3D Systems represents a meaningful advancement that will accelerate the success of our Vantage Ankle prosthesis,” said Exactech CEO Darin Johnson. “Their expertise in surgical planning, as well as medical device design, regulatory, and manufacturing was invaluable in developing this patient-specific solution. The Exactech team is eager to bring this solution to market to simplify ankle arthroplasty’s surgical technique and enhance the patient and surgeon experience.”
 
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.