BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Prime and DYNASTY® Additive Manufacturing Shells

    K Number: K202705 · Decision Aug 20, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    19
    Applicant Total
    37
    Review Days
    338

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    Basic Information

    Device Name
    Prime and DYNASTY® Additive Manufacturing Shells
    K Number
    K202705
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microport Orthopedics, Inc.
    Date Received
    September 16, 2020
    Decision Date
    August 20, 2021
    Product Code
    OQG
    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
    OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

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    Other Clearances by Microport Orthopedics, Inc.

    K Number Device Name
    K250444 NEXUS® Hip Stem
    K243574 Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique
    K240452 Ceramic Femoral Head
    K240043 EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse
    K233507 EVOLUTION® Tibial Cones
    K231947 EVOLUTION® Cement Keel
    K230563 EVOLUTION® Hinge Knee System
    K213817 MPO Knee Instruments; MPO PROPHECY Knee Instruments
    K213816 MPO Hip Instruments
    K200011 E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS
    Search all 37 clearances from Microport Orthopedics, Inc. →