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510(k) Data Aggregation

    K Number
    K040685
    Device Name
    Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY, INC.
    Date Cleared
    2005-01-25

    (315 days)

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

    OSTEOIMPLANT TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Z™ - Series Modular Total Hip System Plasma Coated is indicated for use in total or partial hip replacements in patients suffering severe pain and disability due to structural hip problems such as rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated in patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and failed previous fusion, where bone stock is inadequate for other reconstruction techniques. CP Titanium Plasma Coated Implants are intended for Cement or Press Fit Applications.
    Device Description
    Not Found
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    K Number
    K041443
    Device Name
    OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY, INC.
    Date Cleared
    2004-11-16

    (168 days)

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

    OSTEOIMPLANT TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTI Alumina Ceramic Femoral Head System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, post traumatic arthritis, collagen disorders, avascular necrosis, traumatic arthritis, congenital hip dysplasia, protrusio acetabuli, slipped Capital Femoral Epiphysis, failed previous fusion, where acetabular reconstruction is not possible, and revision of previously failed hip arthroplasty.
    Device Description
    Not Found
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    K Number
    K040225
    Device Name
    OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY, INC.
    Date Cleared
    2004-05-06

    (94 days)

    Product Code
    KWZ
    Regulation Number
    888.3310
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOIMPLANT TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTI Alumina Ceramic Femoral Head System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
    Device Description
    Not Found
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    K Number
    K032729
    Device Name
    Z-SERIES MODULAR TOTAL HIP SYSTEM
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY, INC.
    Date Cleared
    2003-12-03

    (91 days)

    Product Code
    LPH
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOIMPLANT TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Z™ - Series Modular Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
    Device Description
    Not Found
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    K Number
    K030608
    Device Name
    OTI BONE CEMENT PLUG
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY, INC.
    Date Cleared
    2003-06-12

    (106 days)

    Product Code
    JDK
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOIMPLANT TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OTI Bone Cement Plug is intended to allow bone cement pressurization in the intramedullary canal and preventing cement seepage distally. The Bone Plug is placed into the intramedullary canal of the femur at a set distance from the proximal end prior to placement of bone cement and Femoral Prosthesis.
    Device Description
    OTI Bone Cement Plug - Line extension
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    K Number
    K022779
    Device Name
    OTI UNICONDULAR INTERPOSITIONAL SPACER
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY, INC.
    Date Cleared
    2002-11-20

    (90 days)

    Product Code
    HSH
    Regulation Number
    888.3590
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOIMPLANT TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OTI Unicondular Interpositional Spacer is intended for use in the Osteoarthritic knee, where substantial amounts of articular cartlige have been lost as a result of the disease. The prostheses will be used in indications for uncemented treatment of the Tibia articulating surfaces (Medial and Lateral) of the following: Moderate degeneration of the Medial and/or Lateral compartment of the knee (grade II-IV chondromalicia ) and minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the patellofemoral components.
    Device Description
    OTI Unicondular Interpositional Spacer System
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    K Number
    K021822
    Device Name
    R120 MODULAR TOTAL HIP SYSTEM
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY, INC.
    Date Cleared
    2002-07-23

    (49 days)

    Product Code
    JDI, LHP
    Regulation Number
    888.3350
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOIMPLANT TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The R120™ Modular Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The Total Hip System is intended for use with and without bone cement.
    Device Description
    Not Found
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    K Number
    K012762
    Device Name
    MJS POSTERIOR STABILIZED KNEE SYSTEM
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY, INC.
    Date Cleared
    2001-12-11

    (116 days)

    Product Code
    HRY
    Regulation Number
    888.3530
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOIMPLANT TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MJS Posterior Stabilized Knee System is indicated for use in total knee replacement procedures for patients suffering from: - Rheumatoid arthritis. ● - Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose . age, weight, and activity level are compatible with an adequate long-term result. - Failed osteotomies, unicompartmental replacement, or total knee replacement. . The Posterior stabilized system is intended for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact and extra joint stability is required.
    Device Description
    Not Found
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    K Number
    K011774
    Device Name
    R120 MODULAR TOTAL HIP SYSTEM
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY, INC.
    Date Cleared
    2001-09-05

    (90 days)

    Product Code
    JDI, LPH
    Regulation Number
    888.3350
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOIMPLANT TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The R120™ Modular Total Hip System is indicated for use in total or partial hip replacement The X120 - Northering sovere pain and disability due to structural damage in the hip joint from rheumatoid atthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other opplysis, that encation a. The Total Hip System is intended for use with and without bone cement.
    Device Description
    Not Found
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    K Number
    K003316
    Device Name
    OTI CERAMIC FEMORAL HEAD SYSTEM
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY, INC.
    Date Cleared
    2001-01-19

    (88 days)

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

    OSTEOIMPLANT TECHNOLOGY, INC.

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