US-based orthopaedic implant devices maker Exactech has received the US Food and Drug Administration (FDA) 510(k) approval for its Truliant Porous Tibial Tray.
Truliant is a 3D tibial knee implant that leverages additive manufacturing technology to provide a porous structure that mimics the structure of cancellous bone.
The laser-printed tibial tray’s design enables both initial and biological fixation, supporting patients’ active lifestyles.
It features peripherally placed tibial pegs, a dual v-channelled keel and optional cancellous bone screws to enhance initial rotational stability and increase bone-implant interface.
The company said the FDA approval is a significant milestone and strengthens its position to address the growing demand for cementless knee solutions.
Exactech chief marketing officer and large joints senior vice president Adam Hayden said: “With a focus on cementless fixation and increased efficiency, it is no surprise that Truliant Porous is the fastest growing segment of Exactech’s knee portfolio.
“By expanding our porous offerings with the laser-printed tray, knee surgeons will have access to additional sizing and fixation options for the personalisation of their patients’ total knee replacement procedures, improving upon Exactech’s already successful cementless knee.”
Exactech is a medical technology company that provides advanced orthopaedic implants, surgical instruments, and the Active Intelligence (AI) ecosystem of smart technologies.
In August this year, Exactech partnered with Alkem MedTech, a subsidiary of Alkem Laboratories, to manufacture and market its large joint replacement implants in India.
Last month, Exactech announced the completion of the first ankle replacement surgeries using its new Vantage Ankle 3D and 3D+ tibial implants.
The Vantage Ankle 3D and 3D+ tibial implants are designed to provide tibial stem heights from 10 to 30mm, with additional benefits of 3D printing, said the medical device maker.
