Freedom® Total Knee System – Titanium Tibial Base Plate

The Freedom® Total Knee System – Titanium Tibial Base Plate is a total knee replacement component used to treat severe knee joint pain and disability from arthritis, traumatic injury, and other degenerative conditions. The tibial base plate is the metal foundation that anchors the plastic insert to the upper tibia bone and is intended for cemented, single-use application.

The titanium tibial base plate has identical design, geometry, surface features, locking features, and dimensions to the predicate CoCrMo metal-backed tibial component (K090411). The only change is the material of construction from cobalt-chromium-molybdenum alloy to titanium-6aluminum-4vanadium ELI alloy (ASTM F136). Both devices use similar subtractive manufacturing techniques and identical tibial insert locking mechanisms.

ASTM F136 (Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications) and ASTM F1800 (Tibial Tray Fatigue Testing). The biocompatibility assessment references FDA's 2023 Biocompatibility guidance (Use of ISO 10993-1).

Material substitution from CoCrMo to Ti-6Al-4V ELI does not affect device performance because the design and geometry remain identical to the predicate and performance testing demonstrates the new material withstands the same mechanical demands. Titanium alloy is already well-established in orthopedic implants with a long history of safe use, has been used in other components of the same Freedom® system, and is used in similar tibial base plate devices from other manufacturers. The material change does not introduce new types or durations of patient contact, so additional biocompatibility testing is not required.