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510(k) Data Aggregation

    K Number
    K113556
    Device Name
    WAGNER CONE PROSTHESIS SYSTEM
    Manufacturer
    ZIMMER GMBH
    Date Cleared
    2012-02-17

    (78 days)

    Product Code
    LZO,JDI,KWZ,LPH
    Regulation Number
    888.3353
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K032380,K042249
    Predicate For
    K161192,K191781,K212327
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • 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. .
    Device Description

    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.

    AI/ML Overview

    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.

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