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510(k) Data Aggregation

    K Number
    K162237
    Device Name
    XO1 Knee Balancing System
    Manufacturer
    XPANDORTHO, INC.
    Date Cleared
    2017-04-25

    (259 days)

    Product Code
    ONN
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    XPANDORTHO, INC.

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

    The XO1 Knee Balancing System is intended for use as a tool for adjustment of soft tissue to reduce instability from flexion gap asymmetry in total knee replacement procedures.. The XO1 Knee Balancing System requires a resected tibial bone and may only be used with an intact femur, trial femoral implant. The force sensor is sterile, for single patient use.

    Device Description

    Not Found

    AI/ML Overview

    This FDA letter, K162237, for the XO1 Knee Balancing System, does not contain the detailed acceptance criteria or the study data proving the device meets those criteria. The provided text is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a predicate device already on the market. It outlines the indications for use but does not delve into the specific performance studies, acceptance criteria, or the methodology of such studies.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies from the provided document. The document primarily focuses on regulatory clearance rather than detailed performance study reports.

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