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510(k) Data Aggregation

    K Number
    K252788

    Validate with FDA (Live)

    Device Name
    Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)
    Manufacturer
    Tornier, Inc.
    Date Cleared
    2026-01-08

    (128 days)

    Product Code
    PHX
    Regulation Number
    888.3660
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K161742,K211359,K061439,K173900
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Tornier Perform™ Reversed MonoPost Glenoid implant is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

    • Rheumatoid arthritis
    • Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
    • Correction of functional deformity
    • Fractures of the humeral head
    • Traumatic arthritis
    • Revision of glenohumeral joint if native glenoid bone remains

    All components are single use.

    The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation

    Device Description

    The Tornier Perform™ Reversed MonoPost Glenoid (Perform Mono) is intended to replace the native glenoid surface of the scapulohumeral joint as part of a reverse shoulder prosthesis.

    The glenoid implant is composed of a baseplate with a press-fit post, peripheral anchoring screws, and a glenosphere. Ancillary instruments are also provided for the implantation of the prosthesis.

    AI/ML Overview

    N/A

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