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510(k) Data Aggregation

    K Number
    K022382
    Device Name
    RHS ACETABULAR COMPONENT
    Manufacturer
    SIGNAL MEDICAL CORP.
    Date Cleared
    2002-10-04

    (74 days)

    Product Code
    LPH
    Regulation Number
    888.3358
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RHS ACETABULAR COMPONENT

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

    OSTEOARTHRITIS
    RHEUMATOID ARTHRITIS
    TRAUMATIC ARTHRITIS
    WHERE THE USE OF A MORE CONSERVATIVE PROCEDURE HAS FAILED OR IS UNACCEPTABLE
    INTENDED FOR NON-CEMENTED USE SINGLE USE ONLY

    Device Description

    The Signal Medical Corporation HHS Acetabular Component is manufactured of ASTM I-136 or F-75. The design is made available in twelve (12) sizes ranging from 48mm to 70mm, in two mm increments. The cup is coated with an F-67 sintered beaded surface for F-136 or F-75 beads for an F-75 cup to enhance bone ingrowth. The device is designed in three models, one with three circumferentially spaced pins or spikes at 120 degree intervals to provide for a primary skeletal fixation and reduce the chance of rotation, one with screw holes and one with both screw holes and spikes. The ultra high molecular weight polyethylene inserts, ASTM F648, are secured to the acetabular shell using a crown-taper fit. They are designed to accept 28mm femoral heads on their inside diameter from 48mm to 70mm and 32mm femoral heads from 54mm to 70mm. This device is intended for single use only.

    AI/ML Overview

    This document is a 510(k) summary for a medical device (HHS Acetabular Component), not a study report for an AI/ML powered device. As such, it does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details that are typically found in such studies.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or other requested information as it is not present in the provided text.

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