The US Food and Drug Administration (FDA) has granted Exactech 510(k) clearance for its Truliant Porous Tibial Tray, a 3D tibial knee implant designed to enhance fixation.
The implant uses advanced additive manufacturing techniques to create a porous structure that closely resembles a cancellous bone structure.
The structures integrated into this system aim to aid a durable bonding surface to enable immediate and long-term biological fixation while facilitating bony in-growth.
This design is intended to support both initial and long-term biological fixation, catering to the needs of patients with active lifestyles.
The Truliant Porous Tibial Tray features a dual V-channeled keel, strategically positioned tibial pegs and optional screws for increased stability and a larger bone-implant interface.
Exactech Large Joints chief marketing officer and 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 patient's total knee replacement procedures, improving upon Exactech's already successful cementless knee.”
The first surgical procedure using the Truliant Porous Knee Implants was successfully performed in June 2019, with the product officially launched in August 2021.
The design of the system aims to minimise micromotion. The implant has been designed for the patient’s strength and stability.
The addition of integrated bone screw fixation options provides surgeons with intra-operative flexibility to achieve stability.