GAINESVILLE, Fla., October 26, 2023–(BUSINESS WIRE)–Exactech, a developer and manufacturer of innovative implants, instrumentation and smart technologies for joint replacement surgery, today announced the 510(k) clearance of its new 3D printed tibial implants, the Vantage® Only 3D and 3D+. This is the second recent approval for the broader Vantage Total Ankle System, following Activit-E™, a new advanced vitamin E polyethylene, which received approval from the Food and Drug Administration last month.
The new implants provide orthopedic surgeons with additional tibial height options for total ankle replacement patients. Both implants are 3D printed and designed with a porous surface that mimics subchondral bone to aid in biological fixation. They are fitted with pointed pegs and a central bone cage, of varying lengths, to achieve initial fixation. The Vantage Ankle 3D builds on the design philosophy of the system’s current tibial offering and is available in a 10mm height. The Vantage Ankle 3D+ is a stem implant with options of 15, 20, 25 and 30 mm.
“As an original member of the Vantage Ankle design team, I am excited about the next generation, state-of-the-art Vantage Ankle 3D and 3D+ tibial components,” said Mark Easley, MD, of Duke Health. “Developed through the collaborative efforts of our extensive team of expert consultant surgeons and experienced engineers, the redesigned tibial implants feature innovative, intuitive surgical technique and surgeon-friendly instrumentation.”
The Vantage Ankle 3D and 3D+ are compatible with Exactech’s patient-specific instruments, the Vantage Ankle PSI cutting guides. 3D Systems (NYSE:DDD), manufacturer of the Vantage Ankle PSI, previously received 510(k) clearance for four additional cutting guides, two of which are specifically made for use with these new tibial implants.
“We are laser-focused on delivering innovative solutions that our surgeons and patients need,” said Devan Carter, Exactech’s foot and ankle marketing director. “With these new additions, the Vantage Ankle now offers solutions from pre-operative planning to complex deformities, bringing us one step closer to providing a complete continuum of care.”
Full market availability for the Vantage Ankle 3D and 3D+ is expected before the end of 2024. For more information, please contact your local Exactech representative.
About Exactech
Exactech is a global medical device company that develops and markets orthopedic implant devices, related surgical instruments and Active Intelligence® platform of smart technologies for hospitals and doctors. Headquartered in Gainesville, Florida, Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit www.exac.com for more information and connect with us on LinkedIn, VuMedi, YouTube, Tweet and Instagram. With Exactech by your side you have EXACTLY what you need.
Samantha DiVirgilio
Senior Manager Marketing Communications
media@exac.com
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