MedalOne Total Knee System

The MedalOne Total Knee System is a total knee replacement device composed of a cobalt-chrome femoral component, UHMWPE tibial insert, cobalt-chrome tibial base, and UHMWPE patella. It is indicated for knee arthroplasty in skeletally mature patients with degenerative joint disease, rheumatoid arthritis, functional deformity, revision procedures, or unmanageable fractures, and must be used with bone cement for fixation.

The device is substantially equivalent to the predicate EVOLUTION MP Total Knee System in size availability, geometry, nominal dimensions, manufacturing tolerances, processing steps, and materials. Both systems use the same medial-pivot articulation philosophy. The MedalOne components are offered in comparable size ranges (femoral sizes 1-8, tibial sizes 1-8 with extended versions, patellas in 4 sizes) with identical material specifications per ISO standards.

Testing per ISO 14789-1:2000 (tibial baseplate fatigue), ASTM F2182-19 and related MRI safety standards, ISO 10993-1/5/10/11 and ISO/TS 21726 (biocompatibility), and endotoxin testing. Analyses leveraged from predicate include range of motion, femorotibial/patellofemoral contact evaluation, component lock assessment, UHMWPE material characterization, and fatigue strength testing.

The MedalOne system demonstrates substantial equivalence because it has identical indications for use, the same intended patient population, and identical fundamental scientific technology as the predicate EVOLUTION MP. The design features do not create new worst-case scenarios, and nonclinical performance testing shows the device is as safe and effective and performs as well or better than the legally marketed predicate. The only technological difference—branded instrumentation—does not raise different questions of safety or effectiveness.