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510(k) Data Aggregation

    K Number
    K990261
    Device Name
    PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)
    Manufacturer
    PLUS ORTHOPEDICS
    Date Cleared
    1999-08-27

    (212 days)

    Product Code
    LZO
    Regulation Number
    888.3353
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K965002,K980081,K981847,K971409
    Why did this record match?
    Device Name :

    PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)

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

    The INTRAPLANT Ceramic Head Prostheses is intended for use in total hip arthroplasty. The indications for use of the total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedure where previous treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.

    The INTRAPLANT Ceramic Head Prostheses are to be used only with SL-PLUS® and SLR-PLUS® hip stems.

    Device Description

    The INTRAPLANT Ceramic Head Prostheses are manufactured by METOXIT AG (alumina and zirconia). Both come with the standard taper cone 12/14 in six sizes, 28mm (S, M, L) and 32mm (S, M, L).

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called INTRAPLANT Ceramic Head Prostheses. This document describes the device, its intended use, and substantial equivalence to previously marketed devices. It does not contain information about the acceptance criteria for a study, nor does it present a study proving the device meets specific performance criteria in the way typically required for AI/ML or diagnostic devices.

    The relevant section, "Performance data," states only: "Biomechanical testing has been provided." This is a very high-level statement and does not include any specifics about:

    • Specific acceptance criteria (e.g., minimum force, wear rates, fatigue life)
    • The results of biomechanical testing against those criteria
    • Sample sizes, data provenance, ground truth establishment, or expert involvement as would be relevant for software or diagnostic device studies.

    Therefore, I cannot fulfill the request as it pertains to acceptance criteria and a study proving their fulfillment for the INTRAPLANT Ceramic Head Prostheses based solely on the provided text. The information requested (Table of acceptance criteria, sample sizes, experts, adjudication, MRMC, standalone, ground truth, training set information) is entirely absent from this 510(k) summary.

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