Persona Partial Knee

The Persona Partial Knee is a modular partial knee replacement system for the medial compartment of the knee, consisting of a cobalt-chromium-molybdenum femoral component, a titanium tibial tray, and a Vitamin-E crosslinked polyethylene articular surface. It is intended for patients with painful or disabling knee joints due to osteoarthritis, traumatic arthritis, fractures, varus deformities, or revision of previously implanted systems, and is implanted with bone cement.

The subject device has identical intended use, indications for use, materials of construction (Co-Cr-Mo, Ti-6Al-4V, VEHXPE), sterility, and shelf life as the predicate device (K161592). The variants and sizes are similar, and design features are similar to the predicate device.

Not stated in this summary.

The device is substantially equivalent because it introduces Size B as a line extension of an already-cleared product with identical indications for use, materials, intended use, and performance characteristics to the predicate. Performance data confirm the proposed devices meet established acceptance criteria and are as safe and effective as the predicate. Since all critical attributes (materials, sterility, shelf life, design function) are identical or similar, and no new safety or effectiveness questions arise from the size extension, substantial equivalence is demonstrated.