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510(k) Data Aggregation

    K Number
    K971800
    Device Name
    OSTEO CANNULATED SCREW SYSTEM
    Manufacturer
    OSTEONICS CORP.
    Date Cleared
    1997-07-30

    (76 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K980482,K971987,K923238
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Osteo Cannulated Screw System is indicated for the following:

    • Intracapsular fractures of the femoral neck .
    • . Intertrochanteric fractures of the femur
    • Tibial plateau fractures .
    • Fractures of the dorsal pelvic ring .
    • Pelvic sacroiliac joint disruptions .
    • Ankle arthrodesis .
    Device Description

    The Osteo Cannulated Screw System consists of three self-tapping cannulated screws of various lengths, and one washer, which can accommodate any one of the three screws. All devices in the system are provided both sterile. The three screws and washer are manufactured from Titanium 6Al-4V alloy. Two of the three screws have a thread diameter of 6.5mm. One of the two 6.5mm screws has a thread length of 20mm, while the other has a thread length of 40mm. The third screw has an 8.0mm thread diameter and a 25mm thread length. The washer has an outer diameter of 14mm and an inner diameter of 7.5mm.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that the device meets them. The document is a 510(k) premarket notification for the Osteo Cannulated Screw System, which focuses on demonstrating substantial equivalence to predicate devices and outlining the intended use and regulatory classifications. It does not include details on performance studies, sample sizes, ground truth establishment, or expert evaluations.

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