BEUDAMED
    Product Code: KYI FDA class 2 21 CFR 888.3770

    Prosthesis, Wrist, Carpal Trapezium

    Orthopedic

    The Carpal Trapezium Wrist Prosthesis is an orthopedic implant designed to replace the trapezium bone of the wrist, used to treat severe arthritis or injury at the first carpometacarpal joint, particularly to relieve pain and restore thumb function. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KYI, regulated under 21 CFR 888.3770, in the Orthopedic medical specialty. This device is an implant.

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    510(k)s
    26
    FEI Numbers
    21
    Registration Numbers
    21
    Unique Applicants
    16
    Years Active
    42

    Basic Information

    Product Code
    KYI
    Device Class
    FDA class 2
    Regulation Number
    888.3770
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 26 510(k) clearances via K numbers.

    K Number Device Name
    K201072 Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
    K180744 Stablyx CMC Arthroplasty Implant System
    K111068 STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5
    K112278 ASCENSION NUGRIP CMC IMPLANT
    K092548 EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS
    K061956 ARTELON STT SPACER
    K061954 ARTELON CMC SPACER ARTHRO
    K061451 ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
    K061089 MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599
    K060386 NEXA CARPO METACARPAL IMPLANT
    K052596 MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507
    K042690 ASCENSION PYROSPHERE (PCS)
    K040070 ARTELON SPACER CMC-1
    K041451 ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50
    K033529 TIE-IN TRAPEZIUM
    K965204 AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT
    K960659 CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)
    K960534 METALLIC SPHERICAL CMC IMPLANT
    K964472 RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT
    K964381 AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT
    K951471 STRICKLAND TRAPEZIAL IMPLANT
    K864489 SWANSON TITANIUM TRAPEZIUM IMPLANT
    K864488 SWANSON TITANIUM CONDYLAR IMPLANT
    K801952 SPINE ALIGN
    K790508 TRAPEZIO-METACARPAL JOINT SPACER
    K781756 SILASTIC H.P. TRAPEXIAL IMPLANT

    FEI Numbers

    This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.