Truliant leverages additive manufacturing to create a porous structure designed to mimic the structure of cancellous bone. Exactech designed it to facilitate both initial and biological fixation to accommodate patients’ active lifestyles.
The laser-printed 3D tibial tray features peripherally placed tibial pegs, a dual v-channeled keel and optional cancellous bone screws. These combine to increase rotational stability and allow an increased bone-implant interface. Exactech said the FDA clearance marks a significant milestone and positions the company to address the growing demand for cementless knee solutions.
“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,” said Exactech chief marketing officer and SVP of Large Joints, Adam Hayden. “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 nod comes at an interesting time for the Gainesville, Florida-based company. Earlier this week, the company entered a court-supervised Chapter 11 bankruptcy restructuring process. In doing so, it initiated an asset sale supported by existing investors as a “stalking horse” bidder to address legal liabilities.
The restructuring includes an $85 million financing commitment to maintain operations during the process, allowing Exactech to continue its orthopedic device operations and partnerships with surgeons.
Exactech said operations will remain unaffected during the Chapter 11 bankruptcy process
