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510(k) Data Aggregation

    K Number
    K021740
    Device Name
    TOTAL KNEE CEMENTED, SEMI-CONSTRAINED
    Manufacturer
    DJ ORTHOPEDICS, LLC
    Date Cleared
    2002-09-23

    (118 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    DJ ORTHOPEDICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Active Knee® System is indicated to be used only with bone cement in patients suffering from the following conditions: - Noninflammatory degenerative joint disease including osteoarthritis, . traumatic arthritis, or avascular necrosis. - Inflammatory degenerative joint disease including rheumatoid arthritis. ● - Correction of functional deformity such as varus, valgus, or flexion . deformities. - Revision procedures where other treatments or devices have failed. . - . Treatment of fractures that are unmanageable using other techniques. The device is intended for single use only. The Active Knee® System is contraindicated for the following conditions: - Acute or chronic infections, either local or systemic: . - Severe muscular, nervous or vascular disease endangering the leg; . - Defective bone structures, which could impede adequate anchoring of the ● implant: - Patients who are younger than 60 years whose joint disease is such that . good results may be achieved by using other reconstructive procedures such as osteotomy and; - . All associated diseases which could endanger the function and success of the implant.
    Device Description
    The Active Knee System is a modular knee system consisting of a femoral component, a standard meniscal insert, an ultracongruent meniscal insert (tibial insert), a patella, and a tibial baseplate.
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    K Number
    K011354
    Device Name
    HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
    Manufacturer
    DJ ORTHOPEDICS, LLC
    Date Cleared
    2001-07-31

    (89 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    DJ ORTHOPEDICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010594
    Device Name
    DJ ORTHOPEDICS POST SCREW
    Manufacturer
    DJ ORTHOPEDICS, LLC
    Date Cleared
    2001-05-29

    (90 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    DJ ORTHOPEDICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010595
    Device Name
    DJ ORTHOPEDICS INTERFERENCE SCREW
    Manufacturer
    DJ ORTHOPEDICS, LLC
    Date Cleared
    2001-05-08

    (69 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    DJ ORTHOPEDICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002829
    Device Name
    DJ ORTHOPEDICS FEMORAL ANCHOR
    Manufacturer
    DJ ORTHOPEDICS, LLC
    Date Cleared
    2001-03-26

    (196 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    DJ ORTHOPEDICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003960
    Device Name
    DJ ORTHOPEDICS TIBIAL ANCHOR
    Manufacturer
    DJ ORTHOPEDICS, LLC
    Date Cleared
    2001-03-21

    (90 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    DJ ORTHOPEDICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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