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510(k) Data Aggregation

    K Number
    K032824
    Device Name
    STELKAST UNICONDYLAR KNEE SYSTEM
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2003-11-13

    (64 days)

    Product Code
    HSX
    Regulation Number
    888.3520
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STELKAST UNICONDYLAR KNEE SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
      1. Moderate joint impairment from painful arthritis (rheumatoid, osteo and/or posttraumatic).
      1. Revision of a failed unicompartmental knee implant or other procedure.
      1. Alternative to tibial osteotomy in patients with unicompartmental arthritis.
    Device Description

    StelKast Unicondylar Knee System

    AI/ML Overview

    I'm sorry, but this document does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a medical device (StelKast Unicondylar Knee System), which indicates that the device is substantially equivalent to a legally marketed predicate device.

    The clearance letter does not include:

    • Acceptance criteria for device performance.
    • Any study details for evaluating the device's performance against acceptance criteria (e.g., sample size, data provenance, expert involvement, ground truth methods, MRMC studies, or standalone algorithm performance).

    The information provided pertains to regulatory clearance, not performance study outcomes.

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