LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K962224
    Device Name
    SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS
    Manufacturer
    INTERMEDICS ORTHOPEDICS
    Date Cleared
    1996-08-28

    (79 days)

    Product Code
    KWS,HSD,KWT
    Regulation Number
    888.3660
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS

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

    Not Found

    Device Description

    The Select Shoulder Humeral Heads are metallic components manufactured from wrought cobalt chrome alloy (CoCrMo). The heads, once impacted onto one of the Select Shoulder humeral stems, are designed to articulate with the normal human glenoid or with a replacement all-poly glenoid component. The humeral heads feature a female taper which allows for attachment to the male taper of the Internedics Orthopedics Select Shoulder Humeral Stems. The heads are available in a variety of heights and diameters. The humeral heads are designed for use with Intermedics Orthopedics Humeral Stems and/or glenoid components in a variety of sizes for increased stability of the glenohumeral joint.

    AI/ML Overview

    This 510(k) summary does not contain the information requested in your prompt. It describes a medical device (humeral heads) and claims substantial equivalence to existing devices, but it does not include:

    • Acceptance criteria for device performance.
    • Details of a study proving the device meets acceptance criteria.
    • Information on sample sizes, data provenance, expert qualifications, or adjudication methods for ground truth establishment.
    • Any mention of AI, standalone algorithms, or multi-reader multi-case comparative effectiveness studies.
    • Specific ground truth types for training or test sets.

    The document primarily focuses on the product description, material, and a qualitative comparison to similar devices, noting "pull-off strengths... comparable" and "adequate contact area," but without specific performance metrics or detailed study methodologies.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1