BEUDAMED
    Product Code: PKC FDA class 2 21 CFR 888.3660

    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

    Orthopedic

    The Total Anatomic Shoulder Prosthesis with Uncemented Metaphyseal Humeral Stem (Semi-Constrained, No Diaphyseal Incursion) is an orthopedic implant designed for total anatomic shoulder arthroplasty, replacing the humeral head with a metaphyseal-anchored stem that does not extend into the diaphysis, providing fixation without bone cement. It is an FDA Class 2 device regulated under 21 CFR 888.3660, requiring 510(k) premarket notification, within the Orthopedic (OR) medical specialty. The product code is PKC, and it is flagged as an implant. This device is not life-sustaining.

    View on FDA
    510(k)s
    17
    FEI Numbers
    71
    Registration Numbers
    71
    Unique Applicants
    17
    Years Active
    10

    Basic Information

    Product Code
    PKC
    Device Class
    FDA class 2
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

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

    Definition

    Replacement of the humeral head for total anatomic shoulder arthroplasty

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 17 510(k) clearances via K numbers.

    K Number Device Name
    K243248 INHANCE INTACT™
    K241873 OsseoFit Stemless Shoulder System
    K240716 AETOS Shoulder System Stemless Humeral Prosthesis
    K221758 SMR Stemless Anatomic
    K220418 Tornier Perform Humeral System – Stemless
    K213615 Shoulder Innovations Total Shoulder System
    K212683 GLOBAL ICON Stemless Shoulder System
    K203108 Ignite Stemless Anatomic Shoulder System
    K201391 Easytech® Anatomical Shoulder System
    K203100 Arthrex Eclipse Titanium Humeral Head
    K201542 Arthrex Eclipse Shoulder Prosthesis System
    K193226 AltiVate Anatomic Canal-Sparing (CS) Shoulder
    K192097 Exactech® Equinoxe® Stemless Humeral Components
    K182516 Comprehensive Nano Stemless Shoulder
    K173388 Exactech Equinoxe Stemless Shoulder
    K171858 Sidus Stem-Free Shoulder
    K143552 Simpliciti Shoulder System

    FEI Numbers

    This FDA classification entry is associated with 71 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 71 registration numbers. Click on an entry to view related FDA registrations.