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

    GMK HINGE

    K Number: K130299 · Decision Aug 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    39
    Review Days
    189

    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
    GMK HINGE
    K Number
    K130299
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medacta International
    Date Received
    February 7, 2013
    Decision Date
    August 15, 2013
    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 Medacta International

    K Number Device Name
    K160605 MectaLIF Anterior Stand-Alone
    K160289 MasterLoc Stem
    K153664 M.U.S.T. Pedicle Screw System
    K151531 MasterLoc Stem
    K142744 Mecta-C TiPEEK
    K143453 Mpact Double Mobility System
    K142069 GMK EXTENSION
    K141988 M.U.S.T PEDICLE SCREW SYSTEM
    K141044 M.U.S.T. EXTENSION
    K140826 GMK SPHERE EXTENSION
    Search all 39 clearances from Medacta International →