BEUDAMED
    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: KWA FDA class 3

    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

    Orthopedic

    View full classification →

    The Hip Semi-Constrained Metal Uncemented Acetabular Component Prosthesis is a surgical implant designed to resurface or replace the acetabular (socket) side of the hip joint without the use of bone cement, relying on bone ingrowth or press-fit fixation. It is classified as FDA Class 3, the highest risk level, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness before commercial distribution. The product code is KWA, regulated under 21 CFR 888.3330, in the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PROFEMUR Z REVISION HIP STEM
    DYNASTY BIOFOAM SHELL
    METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS
    CONSERVE THIN SHELL
    PRESERVE HIP STEM
    PROFEMUR GLADIATOR HA HIP STEM
    PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER
    GLADIATOR HIP STEM
    CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY
    TAPERLOC COMPLETE MICROPLASTY STEM
    PROFEMUR(R) E CEMENTLESS HIP STEM
    PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM
    GLADIATOR PLASMA CLASSIC HIP STEM
    CONSERVE BIO FOAM SHELL
    TAPERLOC COMPLETE, SIZE 5 AND 6
    ANTERIOR APPROACH HIP SURGERY INSTRUMENTS
    ARCOS INTERLOCKING DISTAL STEMS
    TAPERLOC COMPLETE
    COMPRESS ANTI-ROTATION SPINDLES
    RINGLOC + HYBRID ACETABULAR SYSTEM
    DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110;
    ZIMMER MMC CUP
    METASUL TAPER LINERS, METASUL FEMORAL HEADS
    BIOMET MODULAR FEMORAL REVISION SYSTEM
    PROFEMUR HIP SYSTEM MODULAR NECKS
    REVELATION STEM, MODEL 427-21/42-080/180
    DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER
    DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
    DEPUY ASPHERE M-SPEC HEAD
    BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
    DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM
    PROFEMUR LX 5/8 COATED HIP STEM
    ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM
    PROFEMUR LX REVISION 5/8 COATED HIP STEM
    PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS
    ZIMMER POROLOCK MIS STEM
    DEPUY ASR 300 ACETABULAR CUP SYSTEM
    ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES
    FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38
    ECHO BI-METRIC PRESS-FIT STEMS
    LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS
    DEPUY ASR TAPER SLEEVE ADAPTER
    ALTRA FX HIP SYSTEM
    ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY
    COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG)
    DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
    MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38
    M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT
    ALTRA PRESS-FIT HIP SYSTEM
    DUPUY S-ROM STD HIP STEM PROSTHESIS

    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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump