Tahoe Unicondylar Knee System with TiNbN Overcoat

The Tahoe Unicondylar Knee System (TUKS) with TiNbN Overcoat is an unconstrained, round-on-flat, fixed bearing unicompartmental knee prosthesis designed to replace the medial or lateral compartments of the knee. It is indicated for primary or post-traumatic degenerative disease, varus/valgus deformities, and damage from prior surgery when the opposite compartment and ligaments are preserved. All implants are single-use only and require bone cement for implantation.

The proposed device is identical to the predicate device except for the addition of a monolayer TiNbN coating (3 to 7 microns thickness) applied to the entire surface of both the femoral component and tibial baseplate. The substrate materials, packaging, sterilization method, and shelf life remain the same as the predicate device.

Not stated in this summary. The document references biocompatibility testing data from DOT America for the TiNbN coating and wear testing results for the Consensus Knee System with TiNbN, but does not explicitly cite specific ISO, IEC, or ASTM standards.

Substantial equivalence is based on identical indications for use and design (except for TiNbN coating), substrate material equivalency, and biocompatibility and wear testing data demonstrating that the TiNbN coating does not raise different safety or effectiveness questions compared to the uncoated predicate device. Since the coating is applied to the same substrate and prior wear testing on a similar TiNbN-coated knee system showed no adverse effects on wear performance, additional wear testing was deemed unnecessary.