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510(k) Data Aggregation

    K Number
    K992234
    Device Name
    THE TAPER-FIT TOTAL HIP SYSTEM
    Manufacturer
    CORIN U.S.A.
    Date Cleared
    1999-11-10

    (131 days)

    Product Code
    JDG
    Regulation Number
    888.3360
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    THE TAPER-FIT TOTAL HIP SYSTEM

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

    Relief of pain and restoration of hip function following the effects of osteo, theumatoid and inflammatory arthritis, post-trauma disease, avascular necrosis, and total hip revision. These femoral stems are intended for use with bone cement.

    Device Description

    The Taper-Fit Total Hip System consists of 4 sizes of stem. For each stem size there are 2 offsets 38 mm & 45 mm. A CDH stem is also available with a 36 mm offset. The modular stem is manufactured from Stainless Steel in accordance with BS 7251 Pt 9 -Specification for High Nitrogen Stainless Steel and is provided with a Polymethylmethacrylate Stem Centralizer. The devices are used to resurface femoral hip joints and reinstate function following the degenerative effects of osteo and theumatoid arthritis, post trauma disease, avascular neurosis and septic/aseptic total hip revision. The stem is double tapered, collarless and highly polished. The stem is used with a 316L Stainless Steel Modular Head. This stainless steel complying to BS 7252 Pt 1: 1997, ISO 5832-1:1997 Metallic Materials for Surgical Implants, Part 1. Specification for Wrought Stainless Steel.

    AI/ML Overview

    The provided text describes a 510(k) submission for the Corin Taper-Fit Total Hip System, a medical device. However, it does not contain information about acceptance criteria, device performance metrics, or the details of any study conducted to prove the device meets specific criteria.

    The document details:

    • The device's name and manufacturer.
    • A description of the device components (stem, offsets, material).
    • The intended use (relief of pain and restoration of hip function due to various conditions like arthritis, trauma, avascular necrosis, and total hip revision).
    • The FDA's substantial equivalence determination, allowing the device to be marketed.
    • Regulatory classifications and requirements.

    Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study to prove acceptance criteria, as this information is not present in the provided text. The document is a regulatory approval letter, not a performance study report.

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