Exactech Receives Regulatory Approval for Innovative 3D-Printed Vantage® Ankle Tibial Implants
Friday, October 27, 2023
Exactech, a company known for its pioneering work in implant technology, surgical instruments, and advanced solutions for joint replacement surgeries, has recently revealed that its 3D-printed tibial implants, the Vantage® Ankle 3D and 3D+, have received 510(k) clearance. This announcement follows the recent clearance of Activit-E™, an innovative vitamin E polyethylene, by the Food and Drug Administration just last month, all within the broader Vantage Total Ankle System.
These new tibial implants offer orthopedic surgeons a wider range of options when it comes to tibial height for patients undergoing total ankle replacement procedures. Both implants have a 3D-printed design with a porous surface that emulates subchondral bone, aiding in biological fixation. They incorporate spiked pegs and a central bone cage in various lengths to ensure initial fixation. The Vantage Ankle 3D is an extension of the current tibial implant offering, with a 10mm height variant. On the other hand, the Vantage Ankle 3D+ is a stemmed implant available in heights of 15, 20, 25, and 30mm.
These reimagined tibial implants are the result of collaboration between a team of experienced surgeon consultants and skilled engineers. They bring forth an innovative surgical technique and user-friendly instrumentation. What's more, the Vantage Ankle 3D and 3D+ implants seamlessly integrate with Exactech's patient-specific tools, including the Vantage Ankle PSI cutting guides. Additionally, 3D Systems, the manufacturer of Vantage Ankle PSI, has previously gained 510(k) clearance for four additional cutting guides, with two specifically tailored for use with these newly cleared tibial implants.