LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K994286
    Device Name
    ZMR HIP SYSTEM-POROUS REVISION
    Manufacturer
    ZIMMER, INC.
    Date Cleared
    2000-03-10

    (81 days)

    Product Code
    LPH,LWJ,LZO
    Regulation Number
    888.3358
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K921274,K934412,K992667
    Predicate For
    K031572,K032726,K102424,K113296
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ZMR Hip System is indicated for cementless revision hip arthroplasty. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief or when there is progressive disability.

    Device Description

    The ZMR Porous Revision Hip Prosthesis is a femoral stem manufactured from Tivanium® (Ti-6Al-4V) Alloy and intended for cementless use in revision hip arthroplasty. This device has two modular junctions: a head/neck junction and a midstem junction. Three components are intraoperatively assembled to construct the device: a proximal segment or "body," a distal stem, and a compression nut.

    AI/ML Overview

    I am sorry, but the provided text describes the Zimmer, Inc. ZMR™ Hip System-Porous Revision, a femoral hip prosthesis, and its clearance process with the FDA. This documentation is a 510(k) submission, which is a premarket notification demonstrating substantial equivalence to a legally marketed predicate device.

    The information provided does not include details about acceptance criteria, device performance, or any studies using AI or algorithms. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

    The document is purely a regulatory filing for a physical medical device (a hip replacement system).

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1