FDA OKs Exactech’s New 3D-Printed Vantage Ankle Tibial Implants

Exactech has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its new 3D-printed tibial implants, the Vantage ankle 3D and 3D+.
 
The new implants offer further tibial height options for total ankle replacements. Both are 3D-printed and designed with a porous surface that mimics subchondral bone. They feature spiked pegs and a center bone cage of various lengths for initial fixation.
 
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,” Mark Easley, MD of Duke Health told the press. “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.”
 
Vantage ankle 3D and 3D+ are compatible with Exactech’s patient-specific instrumentation, the Vantage Ankle PSI cutting guides. 3D Systems, maker of the PSI, previously earned 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.”
 
Exactech expects full market release for Vantage ankle 3D and 3D+ in 2024.