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510(k) Data Aggregation

    K Number
    K033930
    Device Name
    KAPP CUSTOM ULNAR HEAD WRIST IMPLANT
    Manufacturer
    KAPP SURGICAL INSTRUMENT, INC.
    Date Cleared
    2004-07-28

    (223 days)

    Product Code
    KXE
    Regulation Number
    888.3810
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KAPP Patient Matched Ulnar Head Wrist Implant is intended to be used for:

    • Replacement of the distal radioulnar joint following ulnar head resection arthroplasty:
    • Replacement of the radial head for degenerative, rheumatoid, or post-traumatic disabilities presenting pain and weakness of the wrist joint and resistance to conservative treatment;
    • Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and
    • Failed ulnar head resection.
      It is intended for patient matched use with bone cement and or press-fit fixation.
    Device Description

    The Kapp Patient Matched Ulnar Head Wrist Implant includes various sizes of implants and accessory surgical instruments. The implant allows for replacement of the ulnar head.

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Kapp Patient Matched Ulnar Head Wrist Implant) and details its identification, description, and indications for use, but does not include performance data, study designs, or acceptance criteria.

    Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

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