LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K183141
    Device Name
    LINK MP Monoblock Hip Prosthesis
    Manufacturer
    Waldemar Link GmbH & Co. KG
    Date Cleared
    2019-02-08

    (87 days)

    Product Code
    LZO
    Regulation Number
    888.3353
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K142187,K161840,K973837
    Why did this record match?
    Device Name :

    LINK MP Monoblock Hip Prosthesis

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

    The LINK ® MP® Monoblock is indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures

    The LINK® MP® Monoblock is indicated for the following conditions:

    • Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone the fixation of a new standard prosthesis is not possible

    • Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture

    The device is intended for cementless use.

    Device Description

    The LINK® MP® Monoblock Hip Prosthesis is a straight hip prosthesis stem. The hip prosthesis is made of Titanium Aluminum Vanadium alloy (Ti-6Al-4V). The prosthesis stems are available in a range of sizes, lengths, CCD angles and offsets. Additional features include a tapered stem with a microporous glass-blasted surface.

    The LINK® MP® Monoblock Hip Prosthesis is designed to be used in conjunction with femoral heads that are manufactured from Cobalt Chromium Molybdenum casting alloy (CoCrMo) or ceramic (BIOLOX® forte and BIOLOX® delta) via 12/14 morse taper (K161840). In total joint use, the femoral head articulates aqainst LINK® BiMobile Cup System (K171273). The LINK® MP® Monoblock Hip Prosthesis provides cementless fixation to the bone.

    AI/ML Overview

    The provided text is related to an FDA 510(k) premarket notification for a medical device, the "LINK® MP® Monoblock Hip Prosthesis." This document concerns the regulatory clearance of a physical medical device (an orthopedic implant), not an AI/ML software.

    Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies related to AI/ML performance is not applicable to this document.

    The document states:

    • "Non-clinical performance testing and analysis were provided, including bench testing." This refers to physical tests on the implant, not a study involving data or AI.
    • "There was no clinical performance testing required for this device." This explicitly states that human clinical trials were not part of this submission for demonstrating substantial equivalence.

    In summary, the provided content does not contain the information requested about AI/ML device performance or the study details typically associated with it.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1