BEUDAMED
    Product Code: NJD FDA class 2 21 CFR 888.3535

    Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

    Orthopedic

    The Unicompartmental/Unicondylar Knee Femorotibial Prosthesis (Uncemented, Porous-Coated, Metal/Polymer) is an orthopedic implant intended to replace part of a knee joint in order to relieve pain and restore knee function for indications including unicompartmental osteoarthritis, inflammatory arthritis, traumatic arthritis, varus/valgus/flexion deformities, and revision surgery. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NJD and regulation 21 CFR 888.3535 in the Orthopedic specialty. The device is flagged as an implant but is not life-sustaining.

    View on FDA
    510(k)s
    5
    FEI Numbers
    19
    Registration Numbers
    19
    Unique Applicants
    4
    Years Active
    11

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    Basic Information

    Product Code
    NJD
    Device Class
    FDA class 2
    Regulation Number
    888.3535
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 5 510(k) clearances via K numbers.

    K Number Device Name
    K251975 Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component
    K242307 ACHIEVE Partial Knee System
    K222653 JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System
    K190439 Engage™ Partial Knee System
    K133811 RESTORIS POROUS PARTIAL KNEE SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.