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The Apex HCLA Acetabular Cup Liners are intended for use with the Apex Modular™ Acetabular Cup, in combination with the Apex Modular, Apex K2™, or Apex K61™ Hip Stem in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

• Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis:
• Rheumatoid arthritis;
• Correction of functional deformity; .
• Congenital dislocation; ●
• Revision procedures where other treatments or devices have failed .
• Femoral neck and trochanteric fractures of the proximal femur.

The Apex HCLA™ Acetabular Cup Liners are manufactured of compression molded, cross-linked and stabilized ultrahigh molecular weight polyethylene, sterilized using ethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 28 mm diameter, with various offsets.

This document describes a 510(k) premarket notification for a medical device (Apex HCLA™ Acetabular Cup Liners), not an AI/ML-driven device or study. Therefore, the information requested in the prompt, which is typically relevant for AI/ML device evaluations (e.g., acceptance criteria for algorithm performance, sample sizes for training/test sets, expert ground truth, MRMC studies, standalone performance), is not applicable to this submission.

The document primarily focuses on establishing "substantial equivalence" of the Apex HCLA™ Acetabular Cup Liners to legally marketed predicate devices based on similarities in design, intended use, material, and manufacturing methods. It does not involve any performance evaluation against acceptance criteria in the context of an AI/ML model.

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