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The Initia Total Hip System is a single use total hip system for use in cementless hip arthroplasty procedures for the following indications: - Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic 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 reconstructive techniques are less likely to achieve satisfactory results, The Initia Total Hip System femoral stems are intended for cementless press-fit use. The Initia Total Hip System acetabular shells are intended for cementless use with biological fixation. 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, rheumatoid arthritis, post-traumatic 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 reconstructive techniques are less likely to achieve satisfactory results.

The Initia Total Hip System is comprised of femoral stems, Co-Cr femoral heads, acetabular shells, an apical hole plug, bone screws and crosslinked polyethylene acetabular liners. The BIOCERAM AZUL® ceramic heads are zirconia toughened alumina (ZTA) ceramic femoral heads compatible with the femoral stems, acetabular shells and acetabular liners of the Initia Total Hip System. The femoral stem is a monoblock wedge tapered design. It is manufactured from forged titanium alloy complying with ASTM F136 and ASTM F620 and is coated with a plasma spray of commercially pure titanium complying with ASTM F1580. The stem is offered in 19 stem sizes which include both standard and high offset neck options, for a total of 38 offerings. The Co-Cr femoral head is manufactured from wrought Co-Cr complying with ASTM F1537. The head has a 12/14 taper bore and is available in outer diameters of 22, 26, 28, 32, 36, 40 and 44 mm. Each head diameter is available in multiple offset options. The acetabular shell is also made from titanium alloy complying with ASTM F136. The acetabular shell is available in outer diameters ranging from 40 mm to 74 mm in 2 mm increments. The outer surface of the shell is coated with a plasma spray of commercially pure titanium complying with ASTM F1580. The acetabular shell is offered in 0 hole, 3 hole, and multi-hole configurations. Self-tapping acetabular bone screws can be used for initial shell fixation. The screws are made from titanium alloy complying with ASTM F136. Bone screws are available in a 6.5 mm diameter and lengths from 15 to 60 mm in 5 mm increments. An apical hole plug, manufactured from titanium alloy complying with ASTM F136, is available to close the apical hole on the acetabular shell. The acetabular liner is made from crosslinked ultra high molecular weight polyethylene (UHMWPE) complying with ASTM F648 and ASTM F2565. The polyethylene liner is offered in inner diameters of 22, 26, 28, 32, 36, 40 and 44 mm with outer diameters to fit the 40 - 74 mm acetabular shells. The liner is offered in 4 configurations: standard (STD), standard with offset (STD HO), elevated rim (MX), and elevated rim with offset (MX HO). The liner mates with the shell using a circumferential locking feature that is integrated into the liner to prevent disassociation. The locking feature mates with a circular groove machined into the shell. The liner also possesses anti-rotation tabs that mate with scallops in the shell. The BIOCERAM AZUL® ceramic head is manufactured from high purity alumina matrix with zirconia reinforcement, which complies with ISO 6474-2. The head has a 12/14 taper bore and is available in outer diameters of 28, 32, 36, 40 and 44 mm. There are 3 offsets (-3.5, +0, +3.5 mm) for the 28 mm size. There are 4 offsets (-3.5, +0, +3.5, +7 mm) for the 32 to 44 mm sizes.