Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K143596
    Device Name
    MINIARS SCREWS
    Manufacturer
    OVERMED SRL.
    Date Cleared
    2016-02-05

    (414 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    OVERMED SRL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MINIARS screw system is intended for fixation of intra-articular fractures, non-union and osteotomies of small bones and small bone fragments. Some examples include: - arthrodesis of small joints (foot and hand surgery); - intra-articular metatarsal and metacarpal fractures; - osteotomies for hallux valgus treatment.
    Device Description
    MINIARS screw system is intended for fixation of intra-articular and extra-articular fractures, non-union and osteotomies of small bones and small bone fragments. MINIARS screws are implants that will be in contact with body tissues for more than 30 days. Instrumentation used to assist in their implantation will be in temporary contact (inferior to 24 hours) with body tissues. The MINIARS screws are intended for single use only. The implant is a solid, one piece, cannulated and partially thread shaped design. MINIARS screws are available in two different external thread diameters: 2.2 mm e 2.6 mm. MINIARS screws are available in a range of lengths from 10mm to 30mm. All the screws sizes available are described in table 5.1. The screws are partially threaded: the proximal and distal parts are threaded while the middle part is cylindrical, as visible in figure 5.1. The thread shape has been designed to facilitate the compression of the bone fragments and the hold in cancellous bone thanks to the particular profile design: the wide thread pitch of the distal part penetrates in bone tissue faster than the thread of the proximal part, reducing and compressing the fracture through screw advance. Distal thread presents self-drilled and self-tapping grooves. The screws present a hexagonal torx 6 head which is conforming to ISO 10664 standard. All the MINIARS screws are supplied in a sterile state (beta rays); the single screw is packed into a double blister which allows the usage in surgery. The MINIARS Screws are made of Titanium Alloy (Ti6A14V ELI gr. 5) and is available in the range of sizes reported in the table below.
    Ask a Question

    Page 1 of 1