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Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
• Certain cases of ankylosis.
  Cemented Components:
  Femoral stem and acetabular cup total hip components labeled "For cemented use only" are indicated only for use with bone cement.

The subject Response 2000 Cemented Hip Stem is intended for cemented use to replace the femoral portion of the hip joint. The subject device is a smooth-stemmed prosthesis which is very similar to the Paramount Hip Stem design, which has been previously cleared by FDA for cemented use.

This 510(k) summary does not contain information related to software or AI/ML. The Response 2000 Cemented Hip Stem is a physical medical device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, experts, and adjudication methods for AI/ML performance is not applicable and not present in this document.

The document describes a typical premarket notification (510(k)) for a conventional medical device, focusing on substantial equivalence to a predicate device based on material, design, intended use, and indications, rather than software performance.

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