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510(k) Data Aggregation

    K Number
    K023086
    Device Name
    CLASSIC GREAT TOE IMPLANT
    Manufacturer
    NEXA ORTHOPEDICS, INC.
    Date Cleared
    2002-10-04

    (17 days)

    Product Code
    KWH
    Regulation Number
    888.3720
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    k981194
    Predicate For
    K023562
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Futura Biomedical Classic Great Toe Implant is indicated for:

    • Hallux limitus or hallux rigidus .
    • . Painful rheumatoid arthritis
    • Hallux abducto valgus associated with arthritis ●
    • Unstable or painful joint from previous surgery .
    Device Description

    The Classic Great Toe Implant is a double-stemmed silicone prosthesis, intended to supplement first metatarsophalangeal joint srthroplasty. The implant is designed to act as a dynamic joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called the "Classic Great Toe Implant." It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain any information regarding clinical studies, performance data, acceptance criteria, or ground truth establishment.

    The document explicitly states that the device is substantially equivalent to a predicate device based on design characteristics and intended use, rather than clinical performance data from studies.

    Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence, not performance evaluation through studies.

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