Freedom® Total Knee System - Porous Tibial Base Plate

The Freedom® Total Knee System – Porous Tibial Base Plate is a tibial component for total knee replacement surgery, used to treat severe knee joint pain and disability from arthritis, trauma, or deformity. It is designed for both cemented and uncemented implantation and is used with compatible Freedom® femoral and tibial liner components.

The device is additively manufactured (EBM) from Ti-6Al-4V ELI Grade 23 titanium with a porous lattice structure on the distal face for bone fixation. It features an asymmetrical design available in eight sizes with left/right configurations, differing from the symmetrical predicate design. Both the subject and predicate use similar materials, additive manufacturing techniques, and dual tray packaging with single-use sterilization.

ASTM F1800 (tibial tray fatigue), ASTM F1877 (residual particle characterization), ASTM F1854/F1160/F1044/F1978/F1147 (porous surface characterization), ISO 11137-2 (sterilization), AAMI ST72 (endotoxin), and ISO 10993-1 and ISO 10993-5 (biocompatibility).

The subject device achieves substantial equivalence through identical intended use (total knee arthroplasty), similar materials and manufacturing methods, and comparable functional design to the predicate TRULIANT device. Minor geometric differences (asymmetrical vs. symmetrical base plate) and sizing variations are supported by equivalent non-clinical performance testing results, particularly residual particle characterization data matching literature values for reference devices, and identical tibial insert locking mechanisms leveraged from an earlier Freedom device.