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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: MBF FDA class 2

    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

    Orthopedic

    View full classification →

    The semi-constrained uncemented metal/polymer shoulder prosthesis is an orthopedic implant designed to replace the glenohumeral joint surfaces in patients with shoulder arthritis or rotator cuff deficiency, providing joint stability through its semi-constrained design and bone ingrowth fixation. It is classified as FDA Class II under 21 CFR 888.3670 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MBF and it carries an implant flag. Full GMP quality system requirements apply.

    510(k) Clearances

    37 matches
    K Number
    Device Name
    Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
    Identity Revision Humeral Stems
    Identity Shoulder System
    Identity Shoulder System
    PRIMA Humeral System; PRIMA TT Glenoid
    SMR Hybrid Glenoid System
    INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid
    INHANCE™ Shoulder System, Sterile Single Use Instrumentation
    SMR Shoulder System
    PRIMA TT Glenoid
    Identity Shoulder System
    INHANCETM Hybrid Anatomic Glenoid Implant
    SMR Reverse Liner
    Ignite Anatomic Shoulder System
    SMR 140° Reverse Humeral Body
    Comprehensive Shoulder System
    SMR Finned Short Stems
    Compress and Mini Compress Anti-Rotation Spindles
    Humeral Short Stem System
    SMR Hybrid Glenoid System
    ARROW Anatomical Porous glenoid
    TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS
    SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM
    COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM
    COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM
    SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM
    ENCORE SHOULDER REVISION GLENOID
    COFIELD TOTAL SHOULDER SYSTEM
    GLOBAL AP POROUS COATED HUMERAL STEM
    VERSA-DIAL HUMERAL HEAD PROSTHESIS
    COMPREHENSIVE PRIMARY SHOULDER STEMS
    BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS
    BI-ANGULAR SHOULDER SYSTEM
    INTERLOK / HA COPELAND RESURFACING HEADS
    GLOBAL FX POROUS-COATED HUMERAL STEM
    GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT
    POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS

    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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