Exactech Announces Clearance for Its New 3D-Printed Vantage® Ankle Tibial Implants

Rhea-AI Summary

Exactech announces 510(k) clearance for its new 3D-printed Vantage Ankle tibial implants, providing orthopaedic surgeons with additional options for total ankle replacement. The implants feature a porous surface for biological fixation and are compatible with patient-specific instrumentation. Full market availability is expected in late 2024.

Positive

• Exactech receives 510(k) clearance for new 3D-printed Vantage Ankle tibial implants, expanding options for total ankle replacement surgery.
• The implants have a porous surface designed to aid with biological fixation.
• Exactech's Vantage Ankle 3D and 3D+ offer additional tibial height options and are compatible with patient-specific instrumentation.
• The Vantage Ankle system provides a full continuum of care, from pre-operative planning to complex deformities.

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• None.

GAINESVILLE, Fla.--(BUSINESS WIRE)-- Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced today 510(k) clearance of its new 3D-printed tibial implants, the Vantage^® Ankle 3D and 3D+. This is the second recent clearance for the broader Vantage Total Ankle System, following Activit-E™, a new advanced vitamin E polyethylene, which received clearance from the Food and Drug Administration last month.

Exactech Announces Clearance for its New 3D-Printed Vantage® Ankle Tibial Implants (Photo: Business Wire)

The new implants provide orthopaedic surgeons with additional tibial height options for total ankle replacement patients. Both implants are 3D-printed and designed with a porous surface mimicking subchondral bone to aid with biological fixation. They feature spiked pegs and a center bone cage, of various lengths, to achieve initial fixation. The Vantage Ankle 3D builds off the design philosophy of the system’s current tibial offering and is available in a 10mm height option. The Vantage Ankle 3D+ is a stemmed implant with 15, 20, 25 and 30mm options.

“As an original Vantage Ankle design team member, 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 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.”

The Vantage Ankle 3D and 3D+ are compatible with Exactech’s patient-specific instrumentation, the Vantage Ankle PSI cutting guides. 3D Systems (NYSE:DDD), the manufacturer of the Vantage Ankle PSI, previously received 510(k) clearance for four additional cutting guides, two of which are made specifically for use with these new tibial implants.

“We’re hyper-focused on delivering innovative solutions our surgeons and patients need,” said Devan Carter, Exactech’s foot and ankle marketing director. “With these new additions, the Vantage Ankle now provides solutions from pre-operative planning to complex deformities, helping us move one step closer to providing a full continuum of care.”

Full market availability for the Vantage Ankle 3D and 3D+ is anticipated for late 2024. For more information, please reach out to your local Exactech rep.

About Exactech

Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence^® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., 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, Twitter and Instagram. With Exactech by your side, you’ve got EXACTLY what you need.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231026002583/en/

Samantha DiVirgilio

Marketing Communications Senior Manager

media@exac.com

Source: Exactech

FAQ

What is the clearance announcement from Exactech about?

Exactech has received 510(k) clearance for its new 3D-printed Vantage Ankle tibial implants, providing orthopaedic surgeons with more options for total ankle replacement.

What features do the new implants have?

The implants have a porous surface mimicking subchondral bone for biological fixation and come with spiked pegs and a center bone cage for initial fixation.

What other product received clearance recently?

Activit-E, a new advanced vitamin E polyethylene, received clearance from the FDA last month.

When will the Vantage Ankle 3D and 3D+ be available in the market?

Full market availability is expected in late 2024.

What other products are compatible with the new implants?

The new implants are compatible with Exactech's patient-specific instrumentation, the Vantage Ankle PSI cutting guides.