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510(k) Data Aggregation

    K Number
    K200575
    Device Name
    TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM
    Manufacturer
    Date Cleared
    2021-07-09

    (491 days)

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

    TRUEMED GROUP LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended use for fixation of complex intra and extra-articular fractures and osteotomies, selective trauma, reconstructive procedures, fusions osteotomies, non-unions, replantations, complex extra articular fractures and fusions of bones of the anatomical regions of the hand, foot and ankle, particularly for osteopenic bone in adults and adolescents.
    Device Description
    The Truemed Hand, Foot and Ankle Plates System consist in a variety of plates designed for specific bone areas, with orifices to receive either locking or non- locking screws. The screws can be total or partially threaded, some are self-tapping and they can be with or without locking features. All plates and screws may be manufactured in either Stainless Steel (ASTM 138 - 13a) or Titanium (ASTM F136-12a).
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    K Number
    K182650
    Device Name
    Arzzt Distal Radius and Ulna System
    Manufacturer
    Date Cleared
    2019-06-10

    (259 days)

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

    Truemed Group LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Arzzt Distal Radius and Ulna System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
    Device Description
    The Arzzt Distal Radius and Ulna System consist in a variety of plates intended for dorsal and volar use, with orifices to receive either locking or non-locking screws. The screws are can be total or partially threaded, some are self-tapping and they can be with or without locking features. System is also available with locking pegs. All plates and screws may be manufactured in stainless steel (ASTM F138) and titanium (ASTM F136). The System is non-sterile and single use only.
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    K Number
    K172189
    Device Name
    Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt
    Manufacturer
    Date Cleared
    2018-01-16

    (180 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    Truemed Group LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ins Hilden Arzzt Nail Systems, consisting of intramedullary solid and cannulated nails, end cap and locking screws, are intended for fixation of fractures of different types: of the shaft, open and closed shaft fractures; and malunion and non-unions of the Femur, Tibia, and Humerus.
    Device Description
    Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt. I. The Ins Hilden Humeral Arzzt is a single use system that consist the following components: - i. Nail, is solid and cannulated, with five orifices, two for distal locking and three for the proximal locking. One of the orifices on the proximal locking is for static locking and one for dynamic locking. Also the nail is milled on the distal end and flat at the proximal end with a threaded insertion/extraction hole. - ii. End caps. - iii. Locking Screws with conical head and self-tapping on the head and blunt. II. The Ins Hilden Femoral Arzzt is a single use system that consist the following components: - i. Nail, is solid and cannulated with four orifices, two for distal locking and two for the proximal locking. One of the orifices on the proximal locking is for static locking and one for dynamic locking. Also the nail is milled on the distal end and flat at the proximal end with a threaded insertion/extractionhole. - ii. End caps. - iii. Locking Screws with conical head and self-tapping on the head and blunt. III. The Ins Hilden Femoral Retrograde Arzzt is a single use system that consist the following components: - i. Nail, is solid and cannulated, with five orifices, two for distal locking and three for the proximal locking. All three proximal orifices for static locking. Also the nail is milled on the distal end and flat at the proximal end with a threaded insertion/extraction hole. - ii. End caps. - iii. Locking Screws with conical head and self-tapping on the head and blunt. IV. The Ins Hilden Cannulated Tibial Arzzt is a single use system that consist the following components: - i. Nail, is cannulated, with four orifices, two for distal locking and four for the proximal locking. All three proximal orifices for static locking. Also the nail is milled on the distal end and flat at the proximal end with a threaded insertion/extraction hole. - ii. End caps. - iii. Locking Screws with conical head and self-tapping on the head and blunt. The system is manufactured from titanium alloy Ti6Al4V, a medical-grade material that is recognized as generally accepted for the manufacture of implants for their level of biocompatibility with surrounding tissues.
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