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510(k) Data Aggregation

    K Number
    K101206
    Device Name
    TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM
    Date Cleared
    2010-07-23

    (84 days)

    Product Code
    Regulation Number
    888.3520
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXANDRIA RESEARCH TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TGS® Unicompartmental Knee Arthroplasty System is intended for arthroplasty of either condyle of a knee with the following indications: 1. Non-inflammatory degenerative joint disease including post-traumatic arthritis and osteoarthritis. 2. Failed previous implant. 3. Correctable deformity. 4. All TGS® UKA System implants are intended for cemented use only. 5. Components of this system are designed for single use and to be used as a system.
    Device Description
    TGS® Unicompartmental Knee Arthroplasty Modular Tibia System (Modular Tibia) is designed to be used with the TGS® Unicompartmental Knee Arthroplasty System (K090024). The Modular Tibia is designed as a two piece construction including a tibial baseplate and a (poly) tibial insert. The tibial baseplate is composed of titanium alloy and is provided in six sizes. The tibial baseplate is indicated for cemented use only. The tibial insert is composed of ultra-high molecular weight polyethylene and is provided in six sizes corresponding to each metal baseplate size. Each tibial insert size is provided in four thicknesses. The tibial insert assembles to a corresponding tibial baseplate with a snap-fit lock mechanism. The Modular Tibia is provided in right and left configurations for use in the medial or lateral tibiofemoral compartment of the knee. The Modular Tibia is packaged sterile with each tibial baseplate and each tibial insert packaged individually.
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    K Number
    K090024
    Device Name
    TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM
    Date Cleared
    2009-05-04

    (119 days)

    Product Code
    Regulation Number
    888.3520
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALEXANDRIA RESEARCH TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TGS Unicompartmental Knee Arthroplasty System is intended for arthroplasty of either condyle of a knee with the following indications: 1. Non-inflammatory degenerative joint disease including post-traumatic arthritis and osteoarthritis. 2. Failed previous implant. 3. Correctable deformity. 4. All TGS® UKA System implants are intended for cemented use only. Components of this system are designed for single use and to be used as a system.
    Device Description
    The TGS® UKA System is composed of unicompartmental femoral components and unicompartmental tibial components. These components may be used in various combinations to create a single unicompartmental femorotibial replacement for either the medial or lateral side of the knee. TGS® UK A System components include individually packaged femoral components made of cobalt-chromium allov and all-poly tibial components of ultra-high molecular weight polyethylene with radiographic markers. The femoral components are available in 6 symmetrical sizes for medial or lateral application in right or left knees. The tibial components are available in two sets of 6 sizes; one set for right-medial or leftlateral tibial plateau, and one set for right-lateral or left-medial tibial plateau. Each tibial component size is available in 5 thicknesses with cither flat or contoured articular surface, and with either two contoured pegs or anterior-posterior (A/P) keel cement/bone fixation features.
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