Search Results

The Exeter X3 RimFit Acetabular Cup is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used with any currently available compatible Howmedica Osteonics' acetabular components. Compatibility with the femoral heads includes: V40 and C-Taper (LFITM, CoCr, Biolox delta, Alumina, and Orthinox).

The indications for use of total hip replacement prostheses include:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum

Stryker's Exeter X3 RimFit Acetabular Cup is intended for cemented use only.

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new Exeter X3 RimFit Acetabular Cup manufactured from a modified sequentially crosslinked and annealed Ultra High Molecular Weight Polyethylene (UHMWPE) material. The proprietary name of the subject polyethylene material is X3® UHMWPE.

The Exeter X3 RimFit Acetabular Cup is a hip prosthesis, and its acceptance criteria and the study proving it meets these criteria are outlined in the provided 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated as a numerical sample size. The testing involved "worst-case size determined by Finite Element Analysis" for the lever-out post fatigue testing. For pull-out testing, it was performed on "cement spacers." The details on the number of specimens tested for each are not provided.
• Data Provenance: The data is from "Non-clinical laboratory testing" performed by the manufacturer, Howmedica Osteonics Corp. This is retrospective, in-house testing designed to demonstrate substantial equivalence to predicate devices. The country of origin for the testing itself is not specified but is implicit to the submitting company (based in Mahwah, NJ, USA).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a mechanical implant, and its performance criteria are based on engineering specifications and mechanical testing, not on expert interpretation of observational data.

4. Adjudication Method for the Test Set

Not applicable. The test set involves mechanical engineering tests, not human judgment, and thus does not require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is a physical hip prosthesis, not an imaging or diagnostic AI tool that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a conceptual sense. The "standalone" performance here refers to the physical device's mechanical properties, which were tested independently without human interaction during the actual performance measurement (other than setting up and operating the testing equipment). The testing was "algorithm only" in that it assessed the device against pre-defined mechanical engineering specifications.

7. The Type of Ground Truth Used

The ground truth used for mechanical testing is based on:

• Established engineering specifications and performance standards outlined in the "FDA Guidance Document entitled 'Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis (April 30, 2002)'".
• Performance of predicate devices (The Trident All Poly Cup, Trident X3 Acetabular Insert, Exeter Hip System With V40 Taper and the Opera Cup). The tests demonstrated "substantial equivalence" to these predicate devices, implying these predicate devices' established performance serves as a comparative ground truth.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (hip prosthesis), undergoes mechanical testing, and does not involve AI/machine learning, therefore there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device