Physica System (Physica CR Porous Femoral components)

The Physica CR Porous Femoral components are uncemented knee prosthesis components made of CoCrMo alloy, designed to replace the femoral condyles in total knee replacement surgery. They are intended for use in skeletally mature patients with degenerative joint disease, rheumatoid arthritis, deformity, revision procedures, or fractures unmanageable by other means.

The subject device has the same sizes, dimensions, and design features as the cleared cemented Physica CR Femoral components, with the key difference being the addition of a porous coating (PoroTi) on internal surfaces for uncemented fixation. The components are manufactured using the same processes and materials as predicate porous femoral components already cleared.

Fatigue testing per ASTM F3210-22e1; PoroTi coating conformity to FDA Guidelines and referenced standards; design controls per FDA guidance.

The device is substantially equivalent because it is based on the cleared Physica CR Femoral cemented components (same geometry and design) combined with the porous coating technology from the cleared Physica Porous Femoral components (same manufacturing and materials). The only difference is removal of cement pockets to enable uncemented fixation. Mechanical testing confirmed performance, and comparisons with multiple previously cleared Physica system components (K141934, K151266, K152008, K193284, K201084, K210554, K211938, K243615) demonstrate functional equivalence with established predicate designs.