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510(k) Data Aggregation

    K Number
    K140898
    Device Name
    PATIENT SPECIFIC DISTAL FEMORAL
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Date Cleared
    2015-01-20

    (287 days)

    Product Code
    KRO
    Regulation Number
    888.3510
    Why did this record match?
    Applicant Name (Manufacturer) :

    STANMORE IMPLANTS WORLDWIDE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Patient Specific Distal Femur is intended for the replacement of diseased or deficient bone in the distal femur. It is indicated for: Limb salvage procedures where radical resection and replacement of the bone is required Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis Correction of varus, valgus or post traumatic deformity Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Ligament deficiencies Tumor resection Revision of previously failed total joint arthroplasty Trauma The Patient Specific Distal Femur and its components are for single use only. The Patient Specific Distal Femur and is components are for cemented use only.
    Device Description
    The Patient Specific Distal Femur is a patient-specific system that is intended for the replacement of diseased or deficient bone in the distal femur. The Patient Specific Distal Femur and its components are intended for cemented use only. The system is comprised of a range of stems, collars coated with hydroxyappetite (HA) or without coating (stippled or smooth), a range of shafts, femoral components (including axle, bushes and circlip), bumpers and a femoral epiphysis component, (i.e. SMILES TKR). The materials used in the manufacture of the Patient Specific Distal Femur include titanium alloy (Ti-6Al-4V), cobalt-chromium-molybdenum (Co-Cr-Mo) and ultra-high molecular weight polyethylene (UHMWPE). The device is for single use only.
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    K Number
    K133152
    Device Name
    JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Date Cleared
    2014-01-22

    (61 days)

    Product Code
    KRO
    Regulation Number
    888.3510
    Why did this record match?
    Applicant Name (Manufacturer) :

    STANMORE IMPLANTS WORLDWIDE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JTS® Extendible Distal Femoral Implant is intended to be used for cemented limb salvage procedures in paediatric (between the ages of 2 and 21) cases where radical resection and replacement of the distal femur is required with the following conditions: - patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment; - surgical intervention for severe trauma, revision knee arthroplasties, failed previous prosthesis and/or oncology indications; and - malignant diseases (e.g., osteogenic sarcoma). The JTS® Extendible Distal Femoral Implant and its components are for single use only.
    Device Description
    The JTS® Extendible Distal Femoral Implant is a patient specific system that is used to replace bone which is lacking or damaged or must be removed (e g., due to tumor). The device consists of components (defined below) which are available in a range of sizes depending on the size and needs of the patient. Every configuration includes a telescoping shaft with a gearbox, magnet, and extension screw assembly for extending the implant when required by the patient. Components available in patient specific sizes: - Femoral Telescoping Shaft - Femoral Block - Extension Screw - Femoral Shaft - Tibial configurations for knee joint including passive rotating hinge, rotating hinge (polyethylene), and metal cased tibia components - Passive Bearing - Tibial Passive Stem - HA Coated Extra-cortical Plate that is integral to the Femoral Shaft - Hydroxyapatite Collar that is integral to the Femoral Shaft - Bumper Pad - Bushes - Axles The specific design of the implant is based on the surgeon's description of the case and patient radiological information. The key dimensions for each JTS® Extendible Distal femoral Implant are derived from the generic device specifications and by taking measurements from the patient's X-rays and/or CT scans. The implant is designed and manufactured for each patient. The JTS® External Drive Unit is used periodically to lengthen the prosthesis when the patient's limb length discrepancy needs to be addressed. The JTS® External Drive Unit creates a magnetic field which interacts with the magnet in the telescoping shaft to lengthen the implant.
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    K Number
    K121056
    Device Name
    METS MODULAR PROXIMAL FEMUR
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Date Cleared
    2012-09-20

    (167 days)

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

    STANMORE IMPLANTS WORLDWIDE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for the replacement of diseased or deficient bone in the proximal femur. It is indicated for: Limb salvage procedures where radical resection and replacement of the bone is required Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis Correction of varus, valgus or post traumatic deformity Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Ligament deficiencies Tumor resections Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques Revision of previously failed total joint arthroplasty Trauma The METS® Modular Proximal Femur and its components are for single use only The METS® Modular Proximal Femur and its components are for cemented use only
    Device Description
    The single use METS® Modular Proximal Femur is a standard modular system that is intended for the replacement of diseased or deficient bone in the proximal femur. The system is intended for cemented use only and comprises titanium (Ti) components including a trochanter section, shaft with or without an integral extension piece, stem and collar that is available hydroxyapatite (HA) coated or uncoated, stippled or smooth. The trochanter trunnion is made to interchange with Stanmore Implants Worldwide Limited's 28mm and 32mm Ø Cobalt Chrome femoral heads. The METS® Modular Proximal Femur is offered with an optional set of trochanters which are only to be used forhard tissue attachment using a plate and two screws, or Ti or cobalt chromium (CoCr) wire. The materials used in the manufacture of the systems include titanium (Ti), cobalt-chromium-molybdenum (CoCrMo)
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    K Number
    K121055
    Device Name
    METS MODULAR TOTAL FEMUR
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Date Cleared
    2012-09-19

    (166 days)

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

    STANMORE IMPLANTS WORLDWIDE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The METS® Modular Total Femur is intended for the replacement of the total femoral bone. Limb salvage procedures where radical resection and replacement of the bone is required Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis Correction of varus, valgus or post traumatic deformity Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Ligament deficiencies Tumor resections Revision of previously failed total joint arthroplasty Trauma Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques All of the METS® Modular Total Femur tibial and acetabular components are for cemented use only All of the METS® Modular Total Femur and their components are for single use only
    Device Description
    The single use METS® Modular Total Femur is a standard modular system that is intended for the replacement of diseased or deficient bone in the femur. The system is intended for cemented use only and comprises titanium (Ti) components including a trochanter section, shaft. The trochanter trunnion is made to interchange with Stanmore Implants Worldwide Limited's, 28mm and 32mm Ø Cobalt Chrome femoral heads. The METS® Modular Total Femur is offered with an optional set of trochanters which are only to be used for hard tissue attachment using a plate and two screws, or Ti or cobalt chromium (CoCr) wire. A range of shafts, femoral component (including axle, bushes and circlip), bumper and the SMILES knee (available in 3 types of arrangements and in a rotating or fixed configuration). The materials used in the manufacture of the systems include titanium (Ti), cobalt-chromium-molybdenum (CoCrMo) and ultra high molecular weight polyethylene (UHMWPE).
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    K Number
    K092138
    Device Name
    JTS EXTENDEABLE IMPLANT
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Date Cleared
    2011-03-22

    (615 days)

    Product Code
    KRO
    Regulation Number
    888.3510
    Why did this record match?
    Applicant Name (Manufacturer) :

    STANMORE IMPLANTS WORLDWIDE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JTS® Extendible Implant is intended to be used for cemented limb sparing procedures in paediatric (between the ages of 2 and 21) cases where radical resection and replacement of the distal femur is required with the following conditions: - . patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment, - surgical intervention for severe trauma, revision knee arthroplasties, failed . previous prostheses and/or oncology indications; and malignant diseases (e.g., osteogenic sarcoma). The JTS® Extendible Implant and its components are for single use only.
    Device Description
    The JTS® Extendible Implant is a patient specific system that is used to replace bone which is lacking or damaged or must be removed (e.g., due to tumor). The JTS® Extendible Implant is a distal femoral (passive hinge tibia) implant. The device consists of components (defined below) which are available in a range of sizes depending on the size and needs of the patient. Every configuration includes a telescoping shaft with a gearbox, magnet, and extension screw assembly for extending the implant when required by the patient. Components available in patient specific sizes: - Femoral Telescoping Shaft . - Femoral Block . - Extension Screw . - Femoral Shaft . - Passive Hinge . - Passive Bearing . - Tibial Passive Stem . - HA Coated Extra-cortical Plate that is integral to the Femoral Shaft . - Hydroxvapatite Collar that is integral to the Femoral Shaft . - Bumper Pad ◆ - Bushes . - Axles . The specific design of the implant is based on the surgeon's description of the case and patient radiological information. The key dimensions for each JTS® Extendible Implant are derived from the generic device specifications and by taking measurements from the patient's X-rays and/or CT scans. The implant is designed and manufactured for each patient. The JTS® External Drive Unit is used periodically to lengthen the prosthesis when the patient's limb length discrepancy needs to be addressed. The JTS® External Drive Unit creates a magnetic field which interacts with the magnet in the telescoping shaft to lengthen the implant.
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