
Exactech Receives Approval for New 3D-Printed Tibial Implants for Small But Fast Growing Ankle Arthroplasty Market
Exactech has announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Vantage® Ankle 3D and 3D+ implants. These 3D-printed tibial implants will enhance the broader Vantage Total Ankle System, and follow the recent FDA clearance of Activit-E for its knee implant in August. Activit-E is comprised of crosslinked polyethylene and does not require gamma irradiation used in other polyethylene implants. The material is resistive to oxidation and extremely strong.
Ankle arthroplasty is becoming more common in the U.S. with rates doubling over the last decade to about 7,000 procedures per year, however, most patients are still treated conservatively.
The newly cleared Vantage Ankle 3D and 3D+ implants offer orthopaedic surgeons additional options in tibial height for patients undergoing total ankle replacement. Utilizing advanced 3D-printing technology, these implants feature a porous surface designed to mimic subchondral bone, aiding in biological fixation. They are also equipped with spiked pegs and a central bone cage in various lengths to ensure initial fixation success. These tibial components can be combined with Exactech’s patient-specific instrumentation, known as the Vantage Ankle PSI cutting guides. 3D Systems, the manufacturer of the Vantage Ankle PSI, previously received 510(k) clearance for four additional cutting guides, two of which are specifically designed for use with the new tibial implants. The Vantage Ankle 3D and 3D+ implants are anticipated to be fully available in the market by late 2024.
Dr. Mark Easley of Duke Health, an original Vantage Ankle design team member, expressed his excitement regarding the new implants. “Developed through the collaborative effort of our expanded team of expert surgeon consultants and experienced engineers, the re-designed tibial implants feature an innovative, intuitive surgical technique and surgeon-friendly instrumentation.”