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510(k) Data Aggregation

    K Number
    K082673
    Device Name
    CONSERVE PRESSFIT FEMORAL COMPONENT
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2008-12-12

    (88 days)

    Product Code
    KXA
    Regulation Number
    888.3400
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K062960,K023188
    Why did this record match?
    Reference Devices :

    K062960, K023188

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CONSERVE® Pressfit Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.

    CONSERVE® Pressfit Femoral Resurfacing Component is intended for non-cemented use

    Device Description

    The design features of the CONSERVE® Femoral Resurfacing Component are summarized below:

    • Manufactured from Cobalt Chrome Alloy
    • 12 Sizes in 2mm increments
    • Plasma Spray undersurface
    AI/ML Overview

    This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it describes a substantial equivalence determination for a medical device.

    Therefore, I cannot fulfill your request as the required information is not present in the provided text.

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