Zimmer Biomet Ceramic Heads (22.2mm diameter)

The Zimmer Biomet Ceramic Heads are hip joint prosthetic components made from composite ceramic (75% alumina, 25% zirconia) in a 22.2mm diameter size. They are used in hip replacement surgery for conditions including osteoarthritis, avascular necrosis, traumatic fractures, failed prior hip surgery, and high-risk dislocation cases when used with constrained acetabular liners.

The subject device is composed of alumina-zirconia ceramic with 12/14 bore or Type 1 bore, designed for tapered titanium alloy stems (Ti-6Al-4V or Ti-6Al-7Nb). The only difference from the predicate device is the addition of a contraindication against use with stainless steel femoral stems; all other technological characteristics remain identical to the predicate.

Not stated in this summary.

Substantial equivalence is established because the subject device differs from the predicate device only in labeling—specifically the addition of a contraindication against stainless steel stem use. Since all physical, chemical, and functional characteristics remain identical to the predicate device, and the change is purely informational, the device maintains substantial equivalence without requiring non-clinical or clinical testing to support the modification.