BIOCERAM AZUL® HEAD

The BIOCERAM AZUL HEAD is a modular ceramic femoral head component for hip replacement surgery. It is used to treat painful hip conditions including degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, and avascular necrosis, as well as for revision of previous unsuccessful hip procedures.

The device is manufactured from the same high-purity alumina matrix with zirconia reinforcement (ISO 6474-2) as the predicate and uses the same taper system, articulating surface, packaging, sterilization, and shelf life. The modification introduces three new sizes: 22 mm outer diameter (with +0 and +3 mm offsets), 26 mm outer diameter (with +0 and +3.5 mm offsets), and an additional +7 mm offset for the existing 28 mm head, all matching or closely similar to metal head variants already cleared in K160895.

ISO 7206-10 (static compression burst test and static pull-off test), ASTM F2345 / ISO 7206-10 (post-fatigue static compression burst test), and ISO 7206-13 (static torsion test).

The new sizes and offsets, though not previously offered for the ceramic head, are identical or very similar to those already cleared for metal heads in the same predicate submission (K160895). The worst-case design passed all mechanical performance tests, demonstrating that the size variations do not introduce new safety or effectiveness concerns. Since the materials, manufacturing, and design principles remain unchanged, and the new dimensional variants are predicated on already-approved metal head configurations, substantial equivalence is supported.