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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: ETA FDA class 2

    Replacement, Ossicular Prosthesis, Total

    Ear, Nose, Throat

    View full classification →

    The total ossicular replacement prosthesis (TORP) is an implantable device used to reconstruct the complete ossicular chain in the middle ear when the malleus, incus, and stapes are damaged or absent, restoring sound transmission from the eardrum to the cochlea. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is ETA, regulated under 21 CFR 874.3495 in the Ear, Nose, Throat specialty. This device is designated as an implant.

    510(k) Clearances

    38 matches
    K Number
    Device Name
    mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
    GRACE DYNAMIC TORP
    SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2
    FISCH TITANIUM MIDDLE EAR PROSTHESES
    KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM
    TITANIUM OSSICULAR REPLACMENT SYSTEM
    MODULAR PORP AND TORP MODEL TBD
    HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES
    GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON
    BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD
    ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM
    MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES
    BOJRAB MICRO-TORP, MODEL 7014-5845
    MILLS COLUMELLA PROSTHESIS
    TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)
    CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
    AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN
    MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS
    TREBAY TOTAL RECTANGULAR HEAD
    RICHARDS TORP
    HAPEX MALLEABLE TORP
    MICROMED TOTAL REGULAR AND PARTIAL OFFSET
    BLACK OVAL-TOP TORP/PORP
    H/A TOTAL-REGULAR, H/A TOTAL-OFFSET
    IONOS(R) OSSICLE 5MM & 7MM
    SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES
    MICROTEK TOTAL OSSICULAR PROTHESIS
    OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL
    OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT
    SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE
    EGG-TOP TORP AND EGG-TOP PORP
    BIOGLASS OSSICULAR RECONSTRUCTION PROSTH
    TOTAL OSSICULAR REPLACEMENT
    AUSTIN MODIFIED PARTIAL OSSICULAR RE-
    AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
    PARTIAL OSSICULAR REPLACEMENT
    CERAVITAL CERAMIC OSSICULAR REPL. PROS.
    SHEA TORP, OTOLOGY IMPLANT

    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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