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    K Number
    K953443
    Device Name
    CONSENSUS PCL SUBSITUTING TIBIAL INSERT
    Manufacturer
    U.S. MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-04-26

    (284 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K912663
    Why did this record match?
    Device Name :

    CONSENSUS PCL SUBSITUTING TIBIAL INSERT

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

    The Consensus® PCL Substituting Tibial Insert is indicated for use in:

      1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
      1. Failed osteotomy or unicompartmental replacements
      1. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
    Device Description

    The Consensus® Knee PCL Substituting Tibial Insert component is manufactured from ultra-high molecular weight polyethylene (ASTM F648). It is an asymmetric cruciate-retaining tibial component and is designed to articulate with the Consensus® Knee primary femoral component. Therefore, it has articulating surface geometry similar to the Consensus® Knee congruent tibial insert component. The inferior surface of each component employs dovetail grooves for positive interlocking with the tibial baseplate. The design is available in three sizes and each size is available in five thicknesses. The Consensus® PCL Substituting Tibial Insert will be provided sterile.

    AI/ML Overview

    The provided text describes a medical device, the Consensus® PCL Substituting Tibial Insert, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study demonstrating the device meets such criteria.

    Specifically, the document states:

    • "Performance Data: The device performs with substantial equivalence to predicate devices."
    • "Clinical Data: None Required"
    • "Conclusions from Non-clinical and Clinical Data: The Consensus® PCL Substituting Tibial Insert is substantially equivalent to the predicate device."

    This indicates that the regulatory approval was based on demonstrating equivalence to an already approved device, rather than explicit acceptance criteria and corresponding performance metrics from a dedicated study of the Consensus® PCL Substituting Tibial Insert itself.

    Therefore, I cannot populate the requested table or provide details about a study proving the device meets acceptance criteria, as that information is not present in the provided text.

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