Zimmer® Persona® Personalized Knee System

The Zimmer Persona Personalized Knee System is a semiconstrained modular knee prosthesis that resurfaces the articulating surfaces of the femoral, tibial, and patellar bones. It is indicated for patients with severe knee pain and disability due to conditions such as osteoarthritis, rheumatoid arthritis, and moderate deformities, using either mechanical or personalized alignment surgical techniques.

The subject device is identical to the predicate in intended use, design features, materials of construction, and sterility. Key differences are limited: removal of the compatibility restriction on cemented nonporous Persona tibial components with stem extensions under the personalized alignment technique, updated geometric evaluations, and shelf-life extension of Vivacit-E VEXLPE components from 5 to 10 years (metallic and conventional UHMWPE components retain their 5 and 10 year shelf lives).

Not stated in this summary.

Substantial equivalence is established because the subject device maintains the same intended use, indications, design, materials, and performance characteristics as the predicate K240299. The primary difference—allowing cemented nonporous tibial components with stem extensions under personalized alignment—does not raise new safety or effectiveness questions, as these are existing Persona components now permitted in additional surgical configurations. The shelf-life extension is supported by performance data demonstrating compliance with acceptance criteria. Therefore, the device is at least as safe and effective as the legally marketed predicate.