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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: PHX FDA class 2

    Shoulder Prosthesis, Reverse Configuration

    Orthopedic

    View full classification →

    The Reverse Configuration Shoulder Prosthesis is an orthopedic implant intended to relieve pain, replace the glenoid and humeral surfaces of the shoulder joint, and restore mobility in patients with grossly rotator cuff-deficient joints, severe arthropathy, or failed prior joint replacements with cuff deficiency. It is an FDA Class 2 device regulated under 21 CFR 888.3660, requiring 510(k) premarket notification, within the Orthopedic (OR) medical specialty. The product code is PHX, and it is flagged as an implant. This device is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Augment Off-Axis Instrument System
    Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System
    MSS - Humeral reverse liners extension
    Veritas Reverse Total Shoulder System
    Comprehensive Reverse Shoulder - HA Glenosphere Baseplates
    Equinoxe® Shoulder System
    InSet Reverse Total Shoulder System
    Blueprint Patient-Specific Instrumentation
    INHANCE™ Reverse Shoulder System
    MSS - Monobloc stem
    SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System
    AltiVate Reverse® ADLC Glenosphere
    N22 EZ Glenosphere
    JARVIS Metaphyseal Stem
    Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)
    MSS - Humeral reverse liners extension
    JARVIS Diaphyseal Stem Standard
    Inset Reverse Total Shoulder System
    JARVIS Glenoid Reverse Shoulder Prosthesis
    AltiVate Reverse® Glenoid
    Equinoxe® Shoulder System
    SMR Reverse HP Shoulder System
    restor3d Reverse Total Shoulder Arthroplasty System
    AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System
    JARVIS Glenoid Reverse Shoulder Prosthesis
    Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid
    Equinoxe® Central Screw Baseplate System
    AltiVate Reverse® Glenoid
    Augment Off-Axis Instrument System
    Full Wedge Lateralized and Augmented Baseplates
    Catalyst F1x Shoulder System
    Augment Off-Axis Instrument System
    BLUEPRINT™ Patient Specific Instrumentation
    LINK Embrace Shoulder System - Reverse Configuration
    Glenoid Reconstruction System – Full Wedge Baseplate
    Catalyst R1 Reverse Shoulder System
    Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
    ARROW Off-Centred Humeral Insert
    FX V135(TM) Shoulder Prosthesis
    Catalyst R1 Reverse Shoulder System
    Arthrex Univers Revers Monoblock Stem Size 4/33
    Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System
    INHANCETM Shoulder System – Humeral Stems and Stemless
    Glenoid Reconstruction System
    Humeris® 135 Shoulder System
    Tornier Perform Humeral System – Fracture
    INHANCETM Reverse Glenoid Peripheral Posts
    Catalyst R1 Reverse Shoulder System
    FX V135 Shoulder Prosthesis
    INHANCE™ Reverse Shoulder System

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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