Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)

The Persona Revision Knee System with the new Persona Revision SoluTion Femoral Components is a knee prosthesis for patients with severe knee pain and disability caused by arthritis, avascular necrosis, post-traumatic joint loss, or deformities. The femoral component articulates with tibial and patellar components as part of a total knee replacement system and is compatible with various augments, cones, and stem extensions.

Both the subject device and predicate are femoral components with equivalent articulating geometry. The key difference is material composition: the predicate uses Co-Cr-Mo alloy, while the subject device uses forged Ti-6Al-4V with Ti-Nidium nitrogen surfacing hardening treatment to improve wear resistance and durability.

Not stated in this summary. The document lists specific test evaluations (fatigue, wear, constraint, augment shear/torque, fretting corrosion, RF-induced heating simulations) but does not cite specific consensus standards (ISO, IEC, ASTM, etc.) by designation.

The subject and predicate devices have identical indications for use and equivalent articulating geometry. Although the material differs (Ti-6Al-4V with surface hardening versus Co-Cr-Mo), the non-clinical testing demonstrates that the subject device maintains comparable mechanical performance, wear characteristics, and biocompatibility. Since the material change does not alter the fundamental function or raise different safety and effectiveness questions, and the subject device performs at least as well as the predicate, substantial equivalence is established.