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510(k) Data Aggregation

    K Number
    K252666

    Validate with FDA (Live)

    Date Cleared
    2025-11-21

    (88 days)

    Product Code
    Regulation Number
    888.1100
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Articulator™ Arthroscopic Bur is indicated for use in orthopedic and arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow, wrist, and hip, to provide abrasion, resection, debridement, and removal of bone and cartilage.

    Device Description

    The Articulator Arthroscopic Bur can be used to abrade, cut and excise tissue and bone in arthroscopic surgeries.

    The arthroscopic bur components include a bur attached to a constant velocity joint that is attached to a long rod rotating within a long hollow stainless steel housing. The bur is shielded on one side by its housing, allowing the bur to cut one structure while tissues on the opposite side of the shield are protected. A pushrod stabilizes the burr housing and holds the articulation into one of three preset flexion angles chosen by the user. A trigger mechanism on the proximal end of the bur allows the user to ergonomically flex and release the working angle of the bur with one hand. This system attaches to a motorized handpiece that drives the internal bur inside the outer housing and provides suction to pull the cut tissue away from the surgical site.

    AI/ML Overview

    N/A

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