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510(k) Data Aggregation

    K Number
    K133579
    Device Name
    MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS
    Manufacturer
    PONTIS ORTHOPAEDICS, LLC
    Date Cleared
    2014-06-26

    (217 days)

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

    PONTIS ORTHOPAEDICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Multifilament stainless steel sutures with crimps are intended for use in soft tissue to bone and bone to bone approximation and fixation during orthopedic procedures in the elbow, foot, ankle, knee, shoulder, and wrist for indications such as: Elbow - biceps tendon attachment; Foot and Ankle - achilles tendon attachment; Knee - patella tendon attachment to bone; Shoulder -biceps tendon tenodesis; Wrist - scapho-lunate approximation.
    Device Description
    Multifilament stainless steel sutures with crimps are intended for use in soft tissue to bone and bone to bone approximation and fixation during orthopedic procedures in the elbow, foot, ankle, knee, shoulder, and wrist for indications such as: Elbow - biceps tendon attachment; Foot and Ankle - achilles tendon attachment; Knee - patella tendon attachment to bone; Shoulder -biceps tendon tenodesis; Wrist - scapho-lunate approximation. Multifilament Stainless Steel Sutures with Crimps are available in a range of USP sizes (4-0 to #3) and lengths, attached to stainless steel needles of various types and sizes. Multifilament SS Sutures are manufactured in IX19, 7X7 or 7X19 filament constructions. The sutures are identified by black and white tips which are used as a guide at the tip, and are removed prior to the end of the procedure. The sutures and tips were cleared for use under the PONTIS 510(k), K101126. The washer is available in the following sizes: 000-0739_1-01 Washer, Plate - 0.012", .045" 000-0739_1-00 Washer, Plate - 0.012", .062" 000-0764 Washer, Plate, 2-Hole - 0.012" The suture guide and the cannulated K-wire are available in one size.
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    K Number
    K140127
    Device Name
    FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
    Manufacturer
    PONTIS ORTHOPAEDICS, LLC
    Date Cleared
    2014-05-28

    (132 days)

    Product Code
    GAQ
    Regulation Number
    878.4495
    Why did this record match?
    Applicant Name (Manufacturer) :

    PONTIS ORTHOPAEDICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ferroFIBRE™ Stainless Steel Suture with Crimp is intended for use in soft tissue approximation and for use in abdominal wound closure. hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair
    Device Description
    The ferroFibre™ with Crimp is a nonabsorbable sterile surgical suture with a crimp composed of stainless steel. The ferroFibre™ with Crimp is available in USP sizes 4-0 to size 3, attached to stainless steel needles of various types and sizes. The ferroFibre™ suture was previously cleared in the K081060. A stainless steel crimp is being added to provide an alternate to knot tying. The use of the crimp for size 3-0 and 4-0 was cleared under submission K101126.
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