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510(k) Data Aggregation

    K Number
    K060131
    Device Name
    OSS-BODIES PROXIMAL TIBIAL SLEEVE
    Manufacturer
    BIOMET MANUFACTURING CORP.
    Date Cleared
    2006-02-15

    (28 days)

    Product Code
    KRO
    Regulation Number
    888.3510
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K052685
    Predicate For
    K081218
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved
    2. Correction of varus, valgus, functional or post traumatic deformity
    3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
    4. Ligament deficiencies
    5. Tumor resections
    6. Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques*
    7. Trauma
    8. Revision of previously failed total joint arthroplasty

    *Not applicable to Regenerex™ Ultra Porous Construct titanium knee augment usage, or any other knee component.

    These devices are single use implants.

    These devices are for cemented use only.

    Device Description

    The Orthopedic Salvage System- OSS offers a variety of component options for the treatments, as well as, resurfacing components for the proximal tibial and distal femur.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that the device meets such criteria.

    The document is a 510(k) summary for a medical device (Orthopedic Salvage System - OSS Bodies-Proximal Tibial Sleeve) seeking clearance from the FDA. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device.

    Specifically, the "Non-Clinical Testing" section states: "An engineering analysis was performed on the modified and predicate Non-Cliffical resultig. An engineering andrysis was possible was functional within its intended use." This indicates some form of engineering analysis, but it doesn't detail acceptance criteria or a study designed to meet them.

    The "Clinical Testing" section explicitly states: "Clinical testing was not required for the predicate device. Therefore, this submission contains no clinical testing." This confirms that no clinical studies were performed for this submission.

    Therefore, I cannot provide the requested information.

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