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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: LPH FDA class 2

    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

    Orthopedic

    View full classification →

    This device is a semi-constrained, porous uncemented hip prosthesis with metal-on-polymer bearing surfaces, used in total hip arthroplasty to replace a diseased or damaged hip joint and achieve fixation through bone ingrowth into the porous coating. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is LPH, regulated under 21 CFR 888.3358, within the Orthopedic medical specialty. This device carries the implant flag, as it is permanently placed within the patient's body.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating
    Taperloc® Complete Hip Stem
    G7® Revision Acetabular System
    Mpact 3D Metal Implants Extension – DMLS Technology
    Velora Acetabular System
    TaperSet™ Hip System
    EMPOWR Acetabular® Liner Extension
    ArTT Augments and Buttresses and Bone Screws
    Stryker and Serf hip devices
    ONVOY™ Acetabular System
    Trinity EVO Acetabular Shell
    Mpact 3D Metal Augments II
    Initia T3 Acetabular Hemispherical Shell System
    Stryker Orthopaedics Hip Devices Labeling Update
    EMPHASYS Acetabular System
    Pantheon Proximal Femur Reconstruction (PFR) System
    MobileLink Acetabular Cup System - Line Extension (Multiple)
    Legend® Acetabular Shell
    OR3O Dual Mobility System
    EMPHASYS Acetabular Shell with RapiTite HA
    Ethylene Oxide Sterilization Supplier Change for MPO Hips
    EMPHASYS™ Dual Mobility System
    Stryker Orthopaedics Hip Systems Labeling Update
    OR3O Dual Mobility Liners
    Mpact Extension
    DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System
    Latitud™ Hip Replacement System
    LINK MobileLink Acetabular Cup System
    BENCOX Mirabo Z Cup Cortinium
    EMPOWR™ blade stem
    My3D® Personalized Pelvic Reconstruction
    CoCr Head
    United U2 femoral head, 22mm delta ceramic head
    ONVOY Acetabular System
    Mg-PSZ Ceramic Femoral Head
    EMPHASYS Acetabular System
    OR3O Dual Mobility System
    My3D® Personalized Pelvic Reconstruction
    Smith & Nephew Hip Systems
    DePuy 3D Additive TriFlange Acetabular Cup
    BENCOX Mirabo Z Cup Cortinium
    BENCOX Mirabo Cup System
    Biocore9 Acetabular Cup System
    Acetabular Dome Hole Plug
    Restoration® Modular Hip System
    R3 Large Head Liners
    Mpact® 3D Metal Implants - DMLS Technology
    E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS
    Bencox THR System
    Provident II Hip Stems

    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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