Consensus Knee System with TiNbN

The Consensus Knee System with TiNbN is a total knee prosthesis intended for primary treatment of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, and degenerative arthritis, as well as for revision cases where bone stock is adequate. It consists of femoral and tibial components manufactured from cast cobalt-chromium-molybdenum (CoCrMo) alloy with a titanium-niobium-nitrogen (TiNbN) coating applied to the implant surfaces.

The subject device is identical to its predicate devices in design, dimensions, tolerances, substrate material, packaging, sterilization method, and shelf life. The sole technological difference is the addition of a monolayer TiNbN coating (3 to 7 microns thick) applied to the entire surface of both femoral and tibial components, whereas predicate devices are uncoated.

ISO 14243-1 (Mode 1 and Mode 3 wear testing conditions); ASTM F75 (cobalt-chromium-molybdenum alloy material specification).

The TiNbN coating does not raise different safety and effectiveness questions than those applicable to predicate devices because the coating's biocompatibility has been demonstrated through exhaustive testing (cytotoxicity, sensitization, irritation, acute systemic toxicity, and implantation), and the underlying substrate material and manufacturing process are identical to predicates. Furthermore, wear testing shows the subject devices achieve superior wear resistance compared to predicate devices under both Mode 1 and Mode 3 conditions, demonstrating performance equivalence or superiority while maintaining the same mechanical and functional characteristics.