BEUDAMED
    Product Code: OYK FDA class 2 21 CFR 888.3110

    Ankle Arthroplasty Implantation System

    Orthopedic

    The Ankle Arthroplasty Implantation System is an orthopedic surgical instrument system intended to assist in the implantation of a specific ankle arthroplasty device by guiding alignment, making or establishing cuts, and sizing. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OYK, with regulation number 888.3110 under the Orthopedic medical specialty; this is a surgical tool, not itself an implant.

    View on FDA
    510(k)s
    7
    FEI Numbers
    13
    Registration Numbers
    13
    Unique Applicants
    3
    Years Active
    4

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    Basic Information

    Product Code
    OYK
    Device Class
    FDA class 2
    Regulation Number
    888.3110
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

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

    Definition

    Intended to be used to assist in the implantation of a specific ankle arthroplasty device. Indicated to include guiding alignment, making or establishing cuts, and sizing.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K243174 Cadence Ankle PSI System
    K243173 Salto Talaris Ankle PSI System
    K241326 Cadence Ankle PSI System
    K241148 Salto Talaris Ankle PSI System
    K231585 Vantage PSI System
    K223326 Axiom PSR System
    K193432 Vantage PSI System

    FEI Numbers

    This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.