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The Osteolock™ Acetabular Cup is intended to be used to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. These components are designed to be press fit into the acetabulum. They do not achieve fixation by biological ingrowth.

This device is a component of a hip joint, semi-constrained, metal/ceramic/polymer, cemented or non-porous uncemented prosthesis. The titaniam plasma spray coating on the outer aspect of the shell provides a roughened surface texture. This plasma spray coating is not a porous coating and, as such, this cup is intended to be press fit into the acetabulum.

The provided text describes a 510(k) submission for the Osteolock™ Acetabular Cup, specifically for an additional indication of uncemented use. However, it does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in evaluation.

The submission is focused on demonstrating substantial equivalence to a previously cleared device (K903362) based on intended use, materials, design, operational principles, and relative indications and contraindications. It states that "Assembly/disassembly testing of the liner from the shell as the characterization of the plasma spray coating was presented in the previous submission." This implies that performance data was likely submitted with the original 510(k) (K903362), but the current document does not detail it.

Therefore, I cannot provide the requested information based solely on the text provided. The document focuses on regulatory approval based on substantial equivalence, not on a detailed device performance study with acceptance criteria.

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