Physica Porous Femoral Components

The Physica Porous Femoral Components are uncemented knee replacement components intended for use in total knee arthroplasty in skeletally mature patients with degenerative joint disease, inflammatory arthritis, functional deformity, failed prior treatments, or unmanageable fractures. The components are part of the broader Physica knee system and are designed to integrate directly with bone without cement.

The subject device has the same intended use, design, and materials as the predicate cleared in K210554. The only change is the addition of a new supplier for the porous coating (PoroTi). The mechanical and morphological characteristics of the new coating were confirmed through comparison testing with the previously cleared cementless Physica Porous Femoral components.

Not stated in this summary.

Substantial equivalence is established because the subject device maintains identical intended use, design, materials, sterilization, packaging, and principle of operation as the predicate device K210554. The sole modification—adding an alternative coating vendor—does not alter performance; non-clinical testing confirmed the PoroTi coating fulfills FDA guidelines and referenced standards on worst-case components. Since design, materials, and function are unchanged, the new coating vendor does not introduce new safety or effectiveness concerns, making the device substantially equivalent to the predicate.