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: ETB FDA class 2

    Prosthesis, Partial Ossicular Replacement

    Ear, Nose, Throat

    View full classification →

    The partial ossicular replacement prosthesis (PORP) is an implantable device used in middle ear surgery to restore the ossicular chain when only part of the chain is missing or damaged, bridging between the remaining stapes or footplate and the tympanic membrane or manubrium. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is ETB, regulated under 21 CFR 874.3450 in the Ear, Nose, Throat specialty. This device is designated as an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
    mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
    NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
    NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
    K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
    NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE
    GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES
    PARTIAL OSSICULAR REPLACEMENT PROSTHESES
    SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS
    CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861
    CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257
    KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652
    SMITH & NEPHEW PISTONS
    SMITH & NEPHEW PORPS & TORPS
    TITANIUM MIDDLE EAR PROSTHESES
    SMITH & NEPHEW OFF-CENTERED PORP
    KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170
    AUDIO TECHNOLOGIES S:R.1
    WEHRS INCUS-STAPES
    CAP PORP, CAP TORP
    MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
    SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE
    STAPES PROSTHESES
    TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010
    EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
    MILLS INCUS HA SLEEVE
    K-PISTON WITH BAND HOOK /ANGULAR PISTON
    PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
    PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)
    CAUSSE PISTON
    BELL PROSTHESIS (PARTIAL)
    ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
    RICHARDS TOTAL/PARTIAL PROSTHESIS
    PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
    PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS
    POLY/PLATINUM WIRE PISTON
    MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
    TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT
    RICHARDS PORP
    HAPES MALLEABLE INCUS STAPES
    HAPEX MALLEABLE PORP
    HAPEX INCUS
    HAPEX PORP
    POLY PISTON
    POLY-WIRE PISTON
    MICROMED PARTIAL REGULAR AND PARTIAL OFFSET
    INCUDOSTAPEDIAL JOINT
    TEF/PLATINUM PISTON
    TEF/WIRE PISTON
    H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET

    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