Exactech, a global medical technology leader, has announced the FDA 510(k) clearance of its Truliant Porous Tibial Tray. This innovative 3D-printed tibial knee implant is designed to facilitate cementless fixation, offering an advanced solution for patients undergoing total knee replacement.
The Truliant Porous Tibial Tray utilizes additive manufacturing to create a porous structure that mimics the architecture of cancellous bone. This design is intended to promote both initial stability and long-term biological fixation, catering to the needs of patients with active lifestyles. The implant aims to provide surgeons with additional options for personalizing total knee replacement procedures.
Key Features of the Truliant Porous Tibial Tray
The Truliant Porous implant incorporates several design elements to enhance its performance:
- Peripherally placed tibial pegs: These pegs are designed to increase initial rotational stability.
- Dual v-channeled keel: This keel further contributes to the implant's stability within the bone.
- Optional cancellous bone screws: These screws provide an additional fixation option, increasing the bone-implant interface.
According to Adam Hayden, Exactech Chief Marketing Officer and Senior Vice President of Large Joints, "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 personalization of their patients’ total knee replacement procedures, improving upon Exactech’s already successful cementless knee."
This FDA clearance represents a significant advancement for Exactech, positioning the company to meet the growing demand for cementless knee replacement solutions. The Truliant Porous Tibial Tray offers a promising option for surgeons seeking to optimize patient outcomes through personalized implant solutions.