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Wagner Cone Prosthesis:
• Noninflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
· Failed previous surgery where pain, deformity, or dysfunction persists.
· Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

Wagner SL Revision Stem Lateral:
· Revision of previously failed hip arthroplasty

The Wagner SL Revision Stem Lateral is a straight stem manufactured from forged titanium alloy and is available in four lengths. The neck design of the stem is provided with the standard 12/14 taper for connection with any Zimmer modular femoral head utilizing a 12/14 taper. The Wagner SL Revision Stem Lateral incorporates a circular stem cross-section and equally spaced conical anchorage ribs, which run nearly the full length of the stem.

The Wagner Cone Prosthesis stem is a straight, collarless stem system designed for uncemented fixation. The surface of the prosthesis is rough blasted, and it has a tapered shape with an angle of five degrees. The stem has eight longitudinal ribs, and it is available in two different CCD angles, 125° and 135°. The stems are available in twelve diameters, ranging from 13 to 24 mm.

This document is a 510(k) summary for the Wagner Cone Prosthesis System and Wagner SL Revision Stem Lateral hip prostheses. It details the substantial equivalence determination made by the FDA. It does not contain information about an AI/ML-based device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, MRMC studies, or standalone performance of an AI/ML device, as this document is not related to such a device.

The document primarily focuses on:

• Device Description: Provides details about the design and materials of the Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis.
• Indications for Use: Lists the medical conditions for which these devices are intended, such as noninflammatory degenerative joint disease, inflammatory joint disease, failed previous surgery, and revision hip arthroplasty.
• Comparison to Predicate Device: States that the intended use has not changed despite proposed modifications to indications for use (limiting them) and packaging configuration. It also mentions a reclassification of some instruments from Class I to Class II.
• Performance Data (Nonclinical and/or Clinical):
  • Non-Clinical: Mentions packaging performance testing according to ISO standards to verify sterile barrier integrity and product protection during sterilization, handling, distribution, and storage. It also notes an amendment of design controls for mechanical integrity and resistance due to the instrument reclassification.
  • Clinical: Explicitly states that "Clinical data and conclusions were not needed for this device." This signifies that a clinical trial or study in humans was not required for this 510(k) submission, likely because equivalence was established through non-clinical testing and comparison to predicate devices.
• Conclusion: Reiterates that the subject devices have the same intended use and similar indications for use, and a similar operating principle, design, labeling, manufacturing, and sterilization processes as the predicate devices. It concludes that observed differences do not raise new questions of safety and effectiveness, and the devices are at least as safe and effective as the legally marketed predicate devices.

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• Noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, ● osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis.
• Failed previous surgery where pain, deformity, or dysfunction persists. .
• Revision of previously failed hip arthroplasty. .

The Wagner Cone Prosthesis stem is a straight, collarless stem system designed for uncemented fixation. The surface of the prosthesis is rough blasted, and it has a tapered shape with an angle of five degrees. The stem has eight longitudinal ribs, and it is available in two different CCD angles, 125° and 135°. The stems are available in twelve diameters, ranging from 13 to 24 mm.

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The provided text is a 510(k) premarket notification for the "Wagner Cone Prosthesis® System." It focuses on:

• Summary of Safety and Effectiveness: This section primarily establishes substantial equivalence to predicate devices.
• Device Description: Describes the physical characteristics of the prosthesis.
• Intended Use: Lists the medical conditions the device is designed to treat.
• Comparison to Predicate Device: Highlights similarities with previously cleared devices.
• Performance Data (Nonclinical and/or Clinical): States that non-clinical tests (Stem and Neck Fatigue Testing, Biocompatibility Testing, and Burst Strength Testing of Ceramic Femoral Heads) were completed, but explicitly mentions "Clinical data and conclusions were not needed for this device."

Therefore, I cannot provide the requested information. The document does not discuss a study with a test set, ground truth establishment, expert adjudication, or other metrics typically associated with proving a device meets acceptance criteria derived from clinical or AI performance studies. The scope of this document is limited to demonstrating substantial equivalence for regulatory clearance, not detailed performance metrics against specific acceptance thresholds.

Ask a specific question about this device