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The FitRite™ Total Hip Arthroplasty System is indicated for total hip replacement in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

The FitRite™ DDH Femoral Stems, Standard Femoral Stems, and Acetabular Cups are intended for cementless application: the FitRite™ Cemented Femoral Stems are intended for cemented application.

The FitRite™ Total Hip Arthroplasty System is used for primary total hip replacement in skeletally mature individuals. The system consists of uncemented femoral stems, CoCr femoral heads in various sizes and offsets, uncemented acetabular cups and conventional polyethylene liners. Instrumentation necessary for proper implantation is also included.

The purpose of this submission is to introduce additional sizing of the cemented stems.

The provided document is a 510(k) premarket notification for a medical device (FitRite™ Total Hip Arthroplasty System). This type of document is submitted to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, and thus does not require clinical trials to prove safety and effectiveness.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, as there are no such studies presented in a 510(k) for substantial equivalence. Specifically:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. The document focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific performance criteria from a new study.
• 2. Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review process is detailed.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a hip arthroplasty system, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable. There is no training set for this type of device submission.
• 9. How the ground truth for the training set was established: Not applicable.

The document explicitly states: "(b)(2) Clinical testing: Clinical testing was not required to demonstrate substantial equivalence in this premarket notification."

The basis for this 510(k) clearance is primarily "(b)(1) Non-clinical testing: Engineering analysis was used to demonstrate that the new sizes of cemented stems do not introduce a new worst case and prior testing conducted on the predicate system demonstrate conformity to the applicable standards." This means the manufacturer relied on existing data and engineering analysis, not new clinical studies or performance studies as typically understood for acceptance criteria.

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