Stryker Orthopaedics Hip Devices Labeling Update

This submission includes femoral stems, femoral heads, acetabular inserts, distal spacers, and bone plugs used in primary or revision hip arthroplasty procedures. The devices are intended for treatment of noninflammatory degenerative joint disease, rheumatoid arthritis, functional deformity correction, and revision procedures where other treatments have failed.

Technological characteristics of the subject devices are identical to those of the predicate devices. The labeling updates in this submission have no impact on the technological characteristics of the subject and predicate devices.

Not stated in this summary.

The substantial equivalence is based on comparison of intended use, indications for use, design, materials, sterilization, technological characteristics, and operational principles between the subject devices and predicate devices. This is a labeling-only change (addition of a contraindication) with no modifications to device design, materials, or function, therefore no new testing was required.