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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: HSD FDA class 2

    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

    Orthopedic

    View full classification →

    An uncemented metallic humeral hemi-shoulder prosthesis is an implant used to replace only the humeral head of the shoulder joint, relying on bone ingrowth rather than cement for fixation, typically in cases of proximal humeral fracture or avascular necrosis. It is classified as an FDA Class 2 device under 21 CFR 888.3690, indicating moderate risk and requiring 510(k) premarket clearance. Product code HSD falls under the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Univers Revers CA Head and Adapter
    Univers Revers Humeral Cup Implant
    AGILON® XO Shoulder Replacement System
    Biocore9 Humeral Resurfacing System
    OVOMotion Shoulder Arthroplasty System
    Arthrex Univers Revers Shoulder Prosthesis System
    Anatomical Shoulder Domelock Dome centric
    Arthrex Univers Revers CA Heads and Adapters
    HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System
    EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
    HUMELOCK II CEMENTLESS SHOULDER SYSTEM
    ARTHREX UNIVERS II CA HEADS
    SEVIIN SURFACE REPLACEMENT SHOULDER
    SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
    SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS
    SPACER-S
    HUMELOCK CEMENTED SHOULDER PROSTHESIS
    DEPUY GLOBAL AP CTA HUMERAL HEAD
    DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
    DVO EXTENDED ARTICULATION HUMERAL HEADS
    SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM
    ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA
    REUNION HA FRACTURE STEM
    PROMOS MODULAR SHOULDER SYSTEM
    AEQUALIS RESURFACING HEAD
    MODULAR REPLACEMENT ELBOW SYSTEM
    AEQUALIS SHOULDER SYSTEM
    ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM
    AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM
    SOLAR PUREFIX HA SHOULDER
    EXACTECH EQUINOXE SHOULDER STEMS
    SPACER-S TEMPORARY SHOULDER SPACER
    COPELAND EAS HUMERAL RESURFACING HEADS
    SOLAR 2 ANATOMIC SHOULDER
    MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS
    PROMOS SHOULDER
    DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS
    GLOBAL CAP RESURFACING REPLACEMENT SHOULDER
    MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM
    CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
    OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
    COPELAND MB/HA RESURFACING HUMERAL HEADS
    COPELAND MB RESURFACING HUMERAL HEADS
    AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
    COPELAND RESURFACING HUMERAL HEADS
    COPELAND RESURFACING HEADS
    ISS OFFSET HEADS
    SOLAR SHOULDER OFFSET HUMERAL HEAD
    ACUMED MODULAR SHOULDER SYSTEM
    BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT

    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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