Freedom® Total Knee System – Titan PCK Components

The Freedom® Total Knee System – Titan PCK Components is a total knee replacement device intended for patients with severe knee pain and disability from arthritis, trauma, or other knee conditions. It consists of femoral, tibial, and patellar components designed for cemented, single-use implantation to restore knee function and mobility in patients with significant bone loss or revision surgery needs.

The only technological change from the predicate devices is the addition of a Titanium Niobium Nitride (TiNbN) surface coating applied to previously cleared femoral augments, tibial augments, stem extensions, offset junctions, and associated screws. All components remain fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V) per ASTM F136, with identical design, dimensions, geometry, and intended use as the uncoated predicate versions.

ASTM F136 for titanium alloy material specification. Coating-specific testing included coating thickness, hardness, and adhesion strength. Mechanical and functional testing leveraged from cleared predicate devices K131481 and K111785, and biocompatibility testing leveraged from cleared device K200912, which has the identical TiNbN coating.

The subject device is substantially equivalent because it shares identical fundamental scientific technology, design, dimensions, geometry, operating mechanism, base material composition, and indications for use with the predicate devices. The TiNbN coating is the only modification, which is equivalent to coatings already cleared in K200912 and K240863. Testing demonstrates the coating does not affect mechanical, functional, or biocompatibility performance, and design hazard analysis confirms no different questions arise regarding safety and effectiveness.