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Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.

Femoral neck fractures.

Correction of functional deformities.

The Vario-Cup System consists of an UHMWPE component encased in an ultra-smooth polished EndoDur (CoCrMo) outer metal casing, for articulation in the bony acetabulum. It is to be used in conjunction with femoral components of the LINK Total Hip Systems. The 22 mm inner diameter Vario-Cup Prostheses are available in outer diameters ranging from 39-43 mm in 1 mm increments. Vario-Cups are self-centering which provides for a functional view of their position in post-op X-rays. An anti-luxation feature resists dislocation: an UHMWPE Safety Ring is placed in a groove at the entrance of the polyethylene insert after assembly of Vario-Cup and femoral components.

This FDA submission focuses on a medical device, the Vario-Cup System, and does not involve AI/ML performance evaluation. Therefore, the requested information about acceptance criteria for AI models, study design for AI models, and related AI-specific details cannot be extracted from the provided text.

The document primarily addresses the substantial equivalence of the Vario-Cup System to predicate devices based on non-clinical performance data, material characterization, and design similarities. It explicitly states that no clinical performance testing was required for this device.

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