Exactech has secured FDA 510(k) clearance for its Truliant porous 3D tibial tray, a 3D-printed tibial knee implant designed to enhance bone integration and stability in total knee replacement procedures. The clearance was announced amidst the company's ongoing Chapter 11 bankruptcy restructuring process.
The Truliant implant leverages additive manufacturing to create a porous structure intended to mimic cancellous bone. This design facilitates both initial and biological fixation, catering to the needs of patients with active lifestyles. The implant aims to improve the longevity and stability of knee replacements by promoting better bone ingrowth.
The laser-printed 3D tibial tray features peripherally placed tibial pegs, a dual v-channeled keel, and optional cancellous bone screws. These features are combined to increase rotational stability and expand the bone-implant interface. According to Exactech, this design addresses the growing demand for cementless knee solutions, potentially leading to improved patient outcomes and reduced revision rates.
"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 Adam Hayden, Exactech chief marketing officer and SVP of Large Joints. "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."
The FDA clearance arrives as Exactech navigates a court-supervised Chapter 11 bankruptcy restructuring, initiated to address legal liabilities. The company has secured an $85 million financing commitment to maintain operations during this period, ensuring the continued manufacturing and distribution of its orthopedic devices. Exactech has stated that its operations will remain unaffected throughout the Chapter 11 process.
