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The Acetabular Cup Orientation (ACO) System is intended to be used as a surgical instrument to place a visual reference k-wire alignment pin to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty procedures. The system utilizes anatomic landmarks of the pelvis that are clearly identifiable on pre-operative CT imaging scans. The ACO System can be used with any 510(k) cleared, legally marketed, hemispherical acetabular cup implant system for primary Total Hip Arthroplasty (THA) and its respective compatible components, with the additions listed below: - · Spherically shaped, symmetrical acetabular cups. - · Without protrusions for fixation such as spikes, threads, pegs, flanges or similar protruding elements. - · Cups with smooth outer surface or uniform coating. · The central axis of the cup matches the direction of impaction; the inner and outer spherical surface of the cup have the same central axis. - · Cups have an apex hole to connect an impactor. - · Allowed deviations from a hemispherical cup shape (as long as the conditions stated above are fulfilled): o Cups with a very slightly flattened dome. - o Cups with one or more holes for fixation with screws. The ACO guides can only be used with hip systems that include reamers and impactors with straight handles. The ACO guides can be used for posterior approach (Moore, also referred to as the 'Southern approach'), postero-lateral approach (Marcy-Fletcher), lateral approach (Hardinge) and antero-lateral approach (Watson-Jones). The ACO guides are intended for single use only.

The Acetabular Cup Orientation System consists of a software component, the Acetabular Cup Orientation Planner and a hardware component, the Acetabular Cup Orientation guides and is designed to assist the surgeon in the pre-op visualization and planning of the acetabular cup orientation and to assist intra-operatively in the orientation of the acetabular cup implant by placement of a visual reference pin. The Acetabular Cup Orientation System is designed for cup orientation guidance within total hip arthroplasty surgery (THA).