Search Results

The BIOCERAM AZUL HEAD is a single use modular femoral head component for use in hip arthroplasty procedures for the following indications: - Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis, - Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure, - Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.

The BIOCERAM AZUL HEAD (the modified device) is identical to the unmodified predicate device in materials, taper system, articulating surface, packaging, sterilization and shelf life, but it differs from the unmodified predicate device in size variation. Labels are different only in reference to the model number and size. The modified device is manufactured from the same high purity alumina matrix with zirconia reinforcement, which complies with ISO 6474-2. Two additional sizes (outer diameters) will be offered: 22 mm and 26 mm. There are 2 offsets (+0, +3 mm) for the 22 mm size and 2 offsets (+0, +3.5 mm) for the 26 mm size; and the current 28 mm head will be offered in an additional offset of +7 mm. These new ODs and offsets are the same or similar to those of the Metal Heads also cleared by K160895.