BEUDAMED
    Product Code: MAY FDA class 2 21 CFR 888.3353

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish

    Orthopedic

    The semi-constrained cemented or non-porous cemented osteophilic finish metal/ceramic/polymer hip prosthesis is an orthopedic implant used to replace the femoral head and acetabular cup in patients with hip joint disease, including osteoarthritis or fracture. It is classified as FDA Class II under 21 CFR 888.3353 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MAY and the implant flag is set, reflecting permanent surgical placement. Full GMP quality system requirements apply.

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    510(k)s
    4
    FEI Numbers
    60
    Registration Numbers
    60
    Unique Applicants
    4
    Years Active
    8

    Basic Information

    Product Code
    MAY
    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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K123604 ABG III MONOLITHIC HIP STEM
    K110807 ABG II MONOLITHIC HIP STEM
    K090103 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL
    K051844 EQUATOR PLUS ACETABULAR CUP SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 60 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 60 registration numbers. Click on an entry to view related FDA registrations.