BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM

    K Number: K081007 · Decision May 6, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    113
    Applicant Total
    376
    Review Days
    28

    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
    ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM
    K Number
    K081007
    Device Class
    FDA class 3
    Clearance Type
    Special
    Regulation Number
    888.3330
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer, Inc.
    Date Received
    April 8, 2008
    Decision Date
    May 6, 2008
    Product Code
    KWA
    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
    KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

    Similar 510(k) Clearances

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

    PROFEMUR Z REVISION HIP STEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    DYNASTY BIOFOAM SHELL

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    CONSERVE THIN SHELL

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    PRESERVE HIP STEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    PROFEMUR GLADIATOR HA HIP STEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic
    View all

    Other Clearances by Zimmer, Inc.

    K Number Device Name
    K261683 Augment Off-Axis Instrument System
    K260831 Z1 Hip System
    K251840 Zimmer® Persona® Personalized Knee System
    K260182 Avenir® Müller Stem; Avenir Complete™ Hip System
    K253592 Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
    K253566 Affixus Retrograde Femoral Nailing System
    K253189 Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
    K252623 G7® Revision Acetabular System
    K251098 Identity Revision Humeral Stems
    K251906 Z1 Hip System
    Search all 376 clearances from Zimmer, Inc. →