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510(k) Data Aggregation

    K Number
    K122883
    Device Name
    EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2013-08-05

    (319 days)

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

    STELKAST COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Proven Gen-Flex™ Total Knee System is intended for: - Total knee replacement due to osteoarthritis. osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems. - Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The device is intended for cemented use only.
    Device Description
    The EXp Tibial Inserts and Patellar Components are made of polyethylene to which Vitamin E has been blended. The tibial inserts are available in "Cruciate Retaining" (CR) and "Posterior Stabilized" (PS) designs. The patellar components are available Single Peg and Three Peg designs. These implants are part of the Proven Gen-Flex™ Total Knee System and will be used in conjunction with a femoral component and tibial baseplate in total knee arthroplasty.
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    K Number
    K122773
    Device Name
    CROSS-OVER ACETABULAR SHELL & LINER
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2012-10-09

    (29 days)

    Product Code
    OQG, JDI, LPH, LWJ, LZO, MAY, OQH, OQI
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    STELKAST COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cross-Over Acetabular Shell and Liner are intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip Arthroplasty. The Cross-Over Acetabular Shell and Liner are used as part of the Provident Hip Systems. The components of this hip system are intended for cementless fixation.
    Device Description
    The Cross-Over Acetabular Shell and Liner will be used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty. The Cross-Over Acetabular Shell is made of titanium alloy with a commercially pure titanium plasma spray coating. The Cross-Over Liner is made of polyethylene blended with Vitamin E. The liner is available in both non-hooded and hooded options.
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    K Number
    K094035
    Device Name
    EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2011-03-24

    (449 days)

    Product Code
    OQG, JDI, LPH, LWJ, LZO, MAY, OQH, OQI
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    STELKAST COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EXp Acetabular Shell Liner is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip Arthroplasty. Cemented and Uncemented Applications
    Device Description
    The EXp Acetabular Shell Liner is made of polyethylene to which Vitamin E has been added. It is available in both hooded and non-hooded options. The liner is part of a complete total hip system and will be used in conjunction with an acetabular shell, femoral head and femoral stem in total hip arthroplasty. The femoral heads which are to be mated with the EXp Liner are made of Biolox forte, Biolox Delta, or CoCr alloy.
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    K Number
    K081458
    Device Name
    PROVEN STEM EXTENDER
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2008-06-06

    (14 days)

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

    STELKAST COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StelKast Proven Stem Extenders are intended for use with compatible components of the Proven Knee System for the following indications: 1. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems; 2. Revision of failed previous reconstructions where sufficient bone stock and soft integrity are present; and 3. Cemented use only.
    Device Description
    Not Found
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    K Number
    K063211
    Device Name
    PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2007-01-18

    (87 days)

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

    STELKAST COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - 1. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems. - 2. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. - 3. For cemented use only.
    Device Description
    Not Found
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    K Number
    K051976
    Device Name
    PROVEN REVISION MODULAR TIBIAL TRAY
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2005-10-17

    (88 days)

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

    STELKAST COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StelKast Proven Revision Modular Tibial Tray is intended for cemented use only in total knee replacement with the following indications: 1. osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems; 2. revision of failed previous reconstructions where sufficient bone stock and soft integrity are present.
    Device Description
    Not Found
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    K Number
    K033944
    Device Name
    STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2004-03-12

    (84 days)

    Product Code
    LZO
    Regulation Number
    888.3353
    Why did this record match?
    Applicant Name (Manufacturer) :

    STELKAST COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 32mm Modular Ceramic Femoral Head is a single use device used for reconstruction of the articulating surface of the femoral head portion of the hip that is severely disabled and/or very painful resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or fracture of the femoral head.
    Device Description
    StelKast 32mm Modular Ceramic Femoral Head
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    STELKAST COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - 1. Moderate joint impairment from painful arthritis (rheumatoid, osteo and/or posttraumatic). - 2. Revision of a failed unicompartmental knee implant or other procedure. - 3. Alternative to tibial osteotomy in patients with unicompartmental arthritis.
    Device Description
    StelKast Unicondylar Knee System
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    K Number
    K031901
    Device Name
    PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2003-10-10

    (112 days)

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

    STELKAST COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. 2. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. 3. For cemented use only.
    Device Description
    Stelkast Proven Cemented, Semi-Constrained Total Knee System
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    K Number
    K032110
    Device Name
    PROCLASS PRESS FIT HIP STEM
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2003-09-22

    (75 days)

    Product Code
    LWJ, LZO
    Regulation Number
    888.3360
    Why did this record match?
    Applicant Name (Manufacturer) :

    STELKAST COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. The ProClass Press Fit Hip Stem is a single use, cementless device used for reconstruction of the articulating surface of the femur portion of the hip that is severely disabled and/or very painful resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or fracture of the femoral head provided there is sufficient sound bone to seat the prosthesis. 2. The stem can be used for primary hip implant or for hip revision of a failed implant. 3. The stem can be used for congenital defects that will allow adequate function of the system.
    Device Description
    ProClass Press Fit Hip Stem is a single use, cementless device.
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