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510(k) Data Aggregation

    K Number
    K171293
    Device Name
    G3™ Active Plate® Miniature System
    Date Cleared
    2017-10-23

    (174 days)

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

    Genesis Fracture Care, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The G3™ Active Plate® Miniature System is intended for fracture fixation in patients 18 years of age and older requiring stabilization of mal-unions, osteotomies and repair of closed and open fractures in small bones. The system is indicated for the fixation of small bone fractures including, but not limited to, fractures of the hand, foot, wrist and ankle.
    Device Description
    The G3™ Active Plate® Miniature System is a straight plate and locking screw system intended to be used for fracture fixation of the hand and foot. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI), medical grade cobalt chrome alloy (Co-28Cr-6Mo) and silicone elastomer in the subject device. The plate has 8 holes. The plates incorporate link elements, which are constrained within the plate and embedded in an elastomer sheath that is bonded to both the link element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. The screws are 1.5 mm diameter and come in lengths ranging from 8 mm to 24 mm.
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    K Number
    K160633
    Device Name
    G3(TM) Active Plate(R) Small Fragment System
    Date Cleared
    2016-04-22

    (46 days)

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

    GENESIS FRACTURE CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The G3™ Acive Plate® Small Fragment system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to <21 years)) cases requiring stabilizations of mal-unions, and osteotomies of long bones, as well as repair of closed and open fractures. The system is indicated for the fixation of long bone fractures including but not limited to fractures of the humerus, tibia, fibula, and radius.
    Device Description
    The G3TM Active Plate® Small Fragment System is a straight plate and locking screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plate and screw are intended to be used for fracture fixation. All implantable components are manufactured from medical grade stainless steel and silicone elastomer the same as the subject device. The screws are 3.5 mm diameter and come in lengths ranging from 10 to 90 mm. The plates range in size from 6 hole to 18 hole. The plates incorporate sliding elements, which are constrained within the plate and embedded in an elastomer sheath that is bonded to the sliding element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. All instruments are made from stainless steel.
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    K Number
    K152242
    Device Name
    G3¿ Active Plate® Large Fragment System
    Date Cleared
    2015-11-24

    (106 days)

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

    GENESIS FRACTURE CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The G3™ Active Plate® Large Fragment system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to <21 years) cases requiring stabilizations of mal-unions, non-unions, and osteotomies of long bones, as well as repair of closed, open and periprosthetic fractures. The system is indicated for the fixation of long bone fractures including but not limited to fractures of the humerus, tibia, and femur, particularly in osteopenic bone.
    Device Description
    The subject G3™ Active Plate® Large Fragment System is a straight plate and locking screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plates and screws are intended to be used for long bone fracture fixation. All implantable components are manufactured from stainless steel (316L) and medical grade titanium alloy (Ti-6Al-4V-ELI). The screws are 5.0 mm diameter and come in lengths ranging from 14 to 145 mm. The plates range in size from 6 holes to 14 holes. The plates incorporate sliding elements, which are constrained within the plate and embedded in an elastomer sheath made from silicone that is bonded to the sliding element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. All instruments are made from stainless steel.
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    K Number
    K150649
    Device Name
    G3 Active Plate Large Fragment System
    Date Cleared
    2015-04-30

    (49 days)

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

    GENESIS FRACTURE CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The system is intended for use in adult and pediation: transitional adolescent B (18 years to <21 years) requiring stabilizations of mal-unions, and osteotomies of long bones, as well as repair of closed and open fractures. The system is indicated for the fixation of long bone fractures included of the humerus, thia, and femur, particularly in osteopenic bone.
    Device Description
    The G3TM Active Plate® Large Fragment System is a straight plate and locking screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plates and screws are intended to be used for long bone fracture fixation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and silicone elastomer in the subject device. The screws are 5.0 mm diameter and come in lengths ranging from 14 to 145 mm. The plates range in size from 6 holes to 14 holes. The plates incorporate sliding elements, which are constrained within the plate and embedded in an elastomer sheath that is bonded to the sliding element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. All instruments are made from stainless steel.
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    K Number
    K142938
    Device Name
    G3 Active Plate Large Fragment System
    Date Cleared
    2014-11-26

    (48 days)

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

    GENESIS FRACTURE CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to <21 years) cases requiring stabilizations of mal-unions, non-unions, and osteotomies of long bones, as well as repair of closed and open fractures. The system is indicated for the fixation of long bone fractures including but not limited to fractures of the humerus, tibia, and femur, particularly in osteopenic bone.
    Device Description
    The G3 ™ Active Plate ® Large Fragment System is a straight plate and locking screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plates and screws are intended to be used for long bone fracture fixation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and silicone elastomer in the subject device. The screws are 5.0 mm diameter and come in lengths ranging from 14 to 145 mm. The plates range in size from 6 holes to 14 holes. The plates incorporate sliding elements, which are constrained within the plate and embedded in a silicone elastomer sheath that is bonded to both the plate and sliding element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. All instruments are made from stainless steel.
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