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510(k) Data Aggregation

    K Number
    K072804
    Device Name
    COMPREHENSIVE RS SHOULDER SYSTEM
    Manufacturer
    BIOMET MANUFACTURING CORP.
    Date Cleared
    2007-12-12

    (72 days)

    Product Code
    PHX,KWS
    Regulation Number
    888.3660
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K021478,K050315,K030941,K041873,K041066,K051075,K052906,K992119,K030710,K043100
    Why did this record match?
    Device Name :

    COMPREHENSIVE RS SHOULDER SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Comprehensive® RS Shoulder System is indicated for use in patients whose shoulder ioint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

    A cemented humeral stem must be used.

    The MacroBond®/HA RS Cleats are indicated only for uncemented biological fixation applications. The GT Baseplate components are intended for cementless application with the addition of screw fixation.

    Device Description

    The Comprehensive® RS Shoulder System is intended for total shoulder replacement in a reverse shoulder.

    AI/ML Overview

    I apologize, but this document is a 510(k) premarket notification decision letter from the FDA for a medical device (Comprehensive® RS Shoulder System), not a study report. It does not contain information about acceptance criteria, device performance metrics, sample sizes, expert qualifications, or any other details related to a scientific study of the device.

    Therefore, I cannot extract the information requested in your prompt from this document. This document mainly addresses the regulatory clearance process, indicating that the device has been deemed substantially equivalent to previously marketed devices.

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