LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060121
    Device Name
    BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS
    Manufacturer
    BIOMET MANUFACTURING CORP.
    Date Cleared
    2006-03-21

    (63 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K033341,K040368,K052178,K052213
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are indicated for use in surgical hip procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as long bone can be identified relative to a CT based model or by an individual 3D model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. These procedures include but are not limited to acetabular cup replacement as part of a partial or total hip arthroplasty (primary or revision).

    Device Description

    The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are reusable conventional manual orthopedic surgical instruments modified with a navigation adapter for use with the BrainLAB VectorVision® Hip Image Guided Surgery System.

    AI/ML Overview

    This 510(k) submission for the "Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications" does not include any clinical trial data or performance studies to demonstrate its acceptance criteria or device performance.

    The submission explicitly states:

    • "Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."
    • "Clinical Testing: None provided as a basis for substantial equivalence."

    Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria because the provided document indicates no such clinical study was performed or submitted. The device received substantial equivalence based on non-clinical testing and comparison to legally marketed predicate devices with "similar technological characteristics."

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1