BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System

    K Number: K252352 · Decision Jan 22, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    203
    Applicant Total
    64
    Review Days
    177

    Basic Information

    Device Name
    SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System
    K Number
    K252352
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lima Corporate S.P.A.
    Date Received
    July 29, 2025
    Decision Date
    January 22, 2026
    Product Code
    PHX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PHX Shoulder Prosthesis, Reverse Configuration

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    Other Clearances by Lima Corporate S.P.A.

    K Number Device Name
    K251718 ArTT Augments and Buttresses and Bone Screws
    K243826 SMR Reverse HP Shoulder System
    K250980 Physica System (Physica CR Porous Femoral components)
    K243615 Physica Porous Femoral Components
    K234011 AMF TT Cones
    K233712 PRIMA Humeral System; PRIMA TT Glenoid
    K231099 SMR Hybrid Glenoid System
    K231925 MINIMA S System
    K221758 SMR Stemless Anatomic
    K223876 SMR Shoulder System
    Search all 64 clearances from Lima Corporate S.P.A. →