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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: HRS FDA class 2

    Plate, Fixation, Bone

    Orthopedic

    View full classification →

    A bone fixation plate is a metallic implant used in orthopedic surgery to stabilize and hold fractured or osteotomized bone segments in position during the healing process. It is classified as an FDA Class 2 device under 21 CFR 888.3030, indicating moderate risk and requiring 510(k) premarket clearance. Product code HRS falls under the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L
    Exalta Proximal Tibia Plating System
    APTUS Clavicle System 2.8
    Pectus Blu System
    Xpert PFP
    Avanti Distal Elbow ORIF System
    OrthoPediatrics® Locking Cannulated Blade Plate System
    I.T.S. PRS Phoenix II
    PC Fix System
    POYA 3.5mm Medial Proximal Tibia System
    SMART Osteotomy System
    enHAnce PEEK Bunion System
    Airlock® Ankle Plating System
    Vortex5 Tailor's Bunion Correction System
    LOQTEQ® VA Proximal Humerus Plate 3.5
    Clavicle Fixation System
    CastleLoc Pectus Bar System
    Super Upper Limbs Versalock Plating System
    APS Spear Locking Plate
    APTUS Shoulder Proximal Humerus System, PentaLock 3.5
    Xpert Hand
    DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System
    DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System
    Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
    VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System
    HKT Anatomical Locking Trauma System
    RIB LINK™ Fixation System
    KLS Martin Ixos System
    KLS Martin Pure Pectus System
    Wrist Fracture System
    Arthrex Variable Angle (VA) Proximal Tibia Plating System
    TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S)
    Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates
    TRILEAP Plating System
    Pectus Versa System
    BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System
    APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista
    KLS Martin Pure Pectus System
    HyperFlex® Bunion Correction System
    SternaFuse Ti Fixation System
    ToeJack MIS Bunion System
    KLS Martin IPS Forearm System
    Geminus Volar Distal Radius Plating System
    WRISTAR MultiAx Distal Radius Kit
    Fine Osteotomy™
    Pediatric Plating Platform I Small-Mini
    MAXXOS P.A.C.E. Foot & Ankle Plating System
    Treace Medical Concepts (TMC) Implant Fixation System
    The Acumed Wrist Fixation System - 2.4mm Screws
    Fine Osteotomy™

    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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