Kinos Total Ankle System

The Kinos Total Ankle System is a fixed bearing, semi-constrained ankle prosthesis designed to replace damaged ankle joint surfaces in patients with severe arthritis or failed previous ankle surgery. The device consists of three components—a tibial implant, bearing implant, and talar implant—that work together to restore alignment, reduce pain, and provide flexion-extension movement. It is intended for cement fixation only.

The device uses additive manufacturing with a TIDAL integrally built porous surface and modular stem fixation (either TIDAL or X-Stem variants). The subject device introduces intermediate sizing options for tibial implants and adds steam (moist heat) sterilization capability, while maintaining the same design and performance characteristics as the predicate.

ISO 17665:2024 is cited for steam sterilization validation. The device is sterilized to a sterility assurance level (SAL) of 1×10⁻⁶. No other consensus standards are explicitly referenced in this summary.

Substantial equivalence is based on identical intended use, indications, performance characteristics, and design between the subject and predicate Kinos Total Ankle System. Although sterilization method differs (steam versus the predicate's method), both achieve the same SAL and match the TIDAL Fusion Cage reference device's sterilization approach. The additional intermediate sizes are bounded by existing minimum and maximum dimensions and introduce no new technological characteristics. Engineering analysis confirms the new sizes present no new worst-case scenarios compared to the predicate.