BEUDAMED
    Product Code: QPP FDA class 2 21 CFR 888.3600

    Implantable Post-Surgical Kinematic Measurement Knee Device

    Orthopedic

    The Implantable Post-Surgical Kinematic Measurement Knee Device is an orthopedic implant that provides objective kinematic data after total knee arthroplasty surgery, with the kinematic data used as an adjunct to other physiological parameter measurement tools during post-surgical patient monitoring and treatment. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 888.3600 in the Orthopedic specialty. It carries product code QPP, is flagged as an implant, and is not life-sustaining.

    View on FDA
    510(k)s
    4
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    2
    Years Active
    3

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    Basic Information

    Product Code
    QPP
    Device Class
    FDA class 2
    Regulation Number
    888.3600
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

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

    Definition

    An implantable post-surgical kinematic measurement knee device is a device that provides objective kinematic data after total knee arthroplasty surgery. The kinematic data provided by the device are used as an adjunct to other physiological parameter measurement tools utilized during the course of patient monitoring and treatment post-surgery.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K234056 canturio® se (Canturio Smart Extension)
    K223803 Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
    K220413 Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
    DEN200064 Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.