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Exactech was granted FDA 510(k) clearance to market Vantage Ankle 3D and 3D+ 3D-printed tibial implants. This is the second recent clearance for the broader Vantage Total Ankle System, following Activit-E, a new advanced vitamin E polyethylene, which received FDA clearance last month.
Full market availability for the Vantage Ankle 3D and 3D+ is anticipated for late 2024.
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, 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.
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.”
Source: Exactech
Exactech was granted FDA 510(k) clearance to market Vantage Ankle 3D and 3D+ 3D-printed tibial implants. This is the second recent clearance for the broader Vantage Total Ankle System, following Activit-E, a new advanced vitamin E polyethylene, which received FDA clearance last month.
Full market availability for the Vantage Ankle 3D and...
Exactech was granted FDA 510(k) clearance to market Vantage Ankle 3D and 3D+ 3D-printed tibial implants. This is the second recent clearance for the broader Vantage Total Ankle System, following Activit-E, a new advanced vitamin E polyethylene, which received FDA clearance last month.
Full market availability for the Vantage Ankle 3D and 3D+ is anticipated for late 2024.
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, 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.
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.”
Source: Exactech
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
