BEUDAMED
    Product Code: OQI FDA class 2 21 CFR 888.3353

    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

    Orthopedic

    The Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented (product code OQI) is an orthopedic hip prosthesis used in total hip arthroplasty. Its indications include degenerative joint disease, rheumatoid arthritis, correction of functional deformity, proximal femur fractures, and revision surgery. As an FDA Class 2 device under regulation 888.3353, it requires 510(k) clearance and falls within the Orthopedic medical specialty. The device is flagged as an implant and is intended for use with cemented or uncemented techniques. It is not life-sustaining.

    View on FDA
    510(k)s
    5
    FEI Numbers
    95
    Registration Numbers
    95
    Unique Applicants
    5
    Years Active
    14

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    Basic Information

    Product Code
    OQI
    Device Class
    FDA class 2
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

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

    Definition

    1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.

    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
    K252451 EPORE® XO cup system
    K192989 Libertas E-XLPE Modular Liner
    K172833 E-XPE Acetabular Components and U-Motion II Acetabular Cup
    K173583 Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners
    K111481 CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS

    FEI Numbers

    This FDA classification entry is associated with 95 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 95 registration numbers. Click on an entry to view related FDA registrations.