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

    Augment Off-Axis Instrument System

    K Number: K261683 · Decision Jun 16, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    203
    Applicant Total
    376
    Review Days
    26

    Basic Information

    Device Name
    Augment Off-Axis Instrument System
    K Number
    K261683
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer, Inc.
    Date Received
    May 21, 2026
    Decision Date
    June 16, 2026
    Product Code
    PHX
    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
    PHX Shoulder Prosthesis, Reverse Configuration

    Similar 510(k) Clearances

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

    Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MSS - Humeral reverse liners extension

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Veritas Reverse Total Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Comprehensive Reverse Shoulder - HA Glenosphere Baseplates

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Equinoxe® Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    InSet Reverse Total Shoulder System

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

    Other Clearances by Zimmer, Inc.

    K Number Device Name
    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
    K250848 Identity Shoulder System
    Search all 376 clearances from Zimmer, Inc. →