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

    EVOLUTION® Hinge Knee System

    K Number: K230563 · Decision Sep 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    37
    Review Days
    210

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EVOLUTION® Hinge Knee System
    K Number
    K230563
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microport Orthopedics, Inc.
    Date Received
    March 1, 2023
    Decision Date
    September 27, 2023
    Product Code
    KRO
    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
    KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KRO), ordered by most recent decision date.

    Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Stem Extension Line (USTAR II System)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Triathlon® Hinge Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATTUNE™ Revision Hinge Knee

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    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

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    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
    K213817 MPO Knee Instruments; MPO PROPHECY Knee Instruments
    K213816 MPO Hip Instruments
    K200011 E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS
    K201157 Prime BIOFOAM® Multi-Hole Shells
    Search all 37 clearances from Microport Orthopedics, Inc. →