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The Precision Casting Solutions Total Hip System implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of: - · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - · Rheumatoid arthritis or traumatic arthritis - · Correction of functional deformity - · Non-union femoral neck fracture - Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques. The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.

The present 510k submission is for a non-cemented primary hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral Head, acetabular poly liner, and acetabular metal (or shell) components. The femoral head component articulates within the poly acetabular component. The poly acetabular component snaps into the metal acetabular component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion. The femoral stem component is made from forged Ti 6AL 4V, with a Ti plasma spray coating. The uni-polar femoral head component is made from CoCr, or BIOLOX® delta ceramic, in 28, 32, and 36 mm sizes. The acetabular poly liner component is made of standard UHMWPE polyethylene in both hooded and non-hooded options. The acetabular poly liner component is offerent inner and outer diameter combinations to accept various size uni-polar femoral heads and acetabular metal components. The acetabular metal (or shell) component is made from forged Ti 6AL 4V with a Ti porous coating. It is available in nohole, cluster-hole, and revision multi-hole styles.