Arthrex iBalance Partial Knee System

The Arthrex iBalance Partial Knee System is a cemented knee prosthesis comprising femoral, tibial, and patellar components for partial knee replacement. It includes three configurations: the UKA (unicompartmental) system for single-compartment disease, the PFJ (patellofemoral) system for patella-femoral arthritis, and the BiCompartmental system combining both UKA and PFJ components for multi-compartment disease.

The proposed device and predicate devices share the same basic design, materials, and intended use. The only modification subject to this 510(k) is a labeling change that includes an updated MR Conditional statement based on non-clinical testing and in-vivo electromagnetic simulation showing the device is MR Conditional.

Not stated in this summary.

Substantial equivalence is established because the Arthrex iBalance Partial Knee System maintains identical basic design features, materials, and indications for use as the predicate devices (K200433 as primary, with multiple reference predicates). The modification is limited to labeling clarification regarding MR safety; no changes to device design, materials, or clinical performance characteristics were made. Non-clinical electromagnetic testing confirmed MR safety, and these findings do not raise different questions of safety or effectiveness compared to existing marketed devices.