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510(k) Data Aggregation

    K Number
    K001984
    Device Name
    PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2000-09-27

    (90 days)

    Product Code
    JDG
    Regulation Number
    888.3360
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
      1. Joint impairment from arthritis (rheumatoid, osteo and post traumatic).
      1. Revision of failed femoral head replacements.
      1. When alternative reconstructive techniques are not viable.
      1. . When arthrodesis is contraindicated.
      1. Avascular necrosis or fracture of the femoral head.
      1. Congenital defects that will allow adequate function of the system.
    Device Description

    Progeny Forged CoCr Cemented Femoral Component

    AI/ML Overview

    I am sorry, but the provided text is a decision letter from the FDA regarding a 510(k) premarket notification for a medical device (Progeny Forged CoCr Cemented Femoral Component).

    This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. It primarily indicates that the device has been found substantially equivalent to a legally marketed predicate device and can proceed to market.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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