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510(k) Data Aggregation

    K Number
    K234056
    Device Name
    canturio® se (Canturio Smart Extension)
    Manufacturer
    Canary Medical USA LLC
    Date Cleared
    2024-04-24

    (124 days)

    Product Code
    QPP
    Regulation Number
    888.3600
    Why did this record match?
    Applicant Name (Manufacturer) :

    Canary Medical USA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The canturio® se (Canturio Smart Extension) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized by the physician during patient monitoring and treatment post-surgery. The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 30mm sized tibial stem extension. The objective kinematic data generated by the canturio® se with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit. The canturio® se with CHIRP System is compatible with Zimmer Personalized Knee System.
    Device Description
    The canturio® se is a tibial extension implant or stem that is attached by the orthopedic surgeon to the Zimmer Biomet Persona® tibial baseplate to form the patient's tibial knee prosthesis. The software and electronics embedded within the canturio® se prosthesis collect the patient's functional movement and gait parameter data post-surgery. Like a traditional tibial extension, the canturio® se provides additional stability in the same manner as a traditional knee extension. The canturio® se (Canturio Smart Extension or CSE) is used with the Canary Health Implanted Reporting Processor (CHIRP) System which is comprised of the following subsystems: - Operating Room Base Station Subsystem ("OR BS"), - Home Base Station Subsystem (“HBS”), - Canary Cloud Data Management Platform ("Cloud" or "CMDP") subsystem and - Canary Medical Gait Parameters (CMGP) software module. Each CHIRP subsystem combines physical components, electronics, software, and user interfaces to collect, store, analyze, transmit, and display patient data for use by both physicians and patients.
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    K Number
    K223803
    Device Name
    Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
    Manufacturer
    Canary Medical USA LLC
    Date Cleared
    2023-03-24

    (95 days)

    Product Code
    QPP, OPP
    Regulation Number
    888.3600
    Why did this record match?
    Applicant Name (Manufacturer) :

    Canary Medical USA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized by the physician during the course of patient monitoring and treatment post-surgery. The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58mm sized tibial stem extension. The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit. The CTE with CHIRP System is compatible with Zimmer Persona® Personalized Knee System.
    Device Description
    The Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is comprised of the following subsystems: Canary Tibial Extension (CTE) implant, Operating Room (OR) Base Station System ("BS1"), Home Base Station System ("BS2"), Canary Cloud Data Management Platform ("Cloud") and Canary Medical Gait Parameters (CMGP software module). The CTE and CHIRP System is intended to provide objective kinematic data on patient's total knee arthroplasty (TKA) function. The kinematic data produced by the CTE implant is intended as an adjunct to other physiological measurement tools post TKA surgical care while providing additional tibial stability afforded by traditional tibial extensions of similar length. The implanted CTE collects data from internal motion sensors, and when queried by a BS1 or BS2 over a communication interface, transmits the motion data to the Base Station System. The Base Station System, in turn, uploads the data to the Canary Cloud Data Management Platform. The User is defined as the Patient with the CTE and CHIRP System and their designated Health Care Professional (HCP) with access to the Patient's CTE data. The CTE is designed for use with the Zimmer Biomet Persona Personalized Knee System tibial baseplate, to provide additional stability and collect kinematic data to assist the physician in monitoring patient activity following total knee arthroplasty (TKA) in between office visits. The Canary Quantiles Recovery Curves software is an accessory and an optional software module for use with the CTE with CHIRP System. The software obtains kinematic data from the CTE with CHIRP System and provides aggregation and visualization of patient population data to HCPs to analyze patient recovery progress and direction of outcome.
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    K Number
    K220413
    Device Name
    Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
    Manufacturer
    Canary Medical USA LLC
    Date Cleared
    2022-06-22

    (128 days)

    Product Code
    QPP
    Regulation Number
    888.3600
    Why did this record match?
    Applicant Name (Manufacturer) :

    Canary Medical USA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty (TKA) postsurgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized by the physician during the course of patient monitoring and treatment post-surgery. The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58mm sized tibial stem extension. The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decisionmaking and have not been shown to provide any clinical benefit. The CTE with CHIRP System is compatible with Zimmer Personalized Knee System.
    Device Description
    The Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is comprised of the following subsystems: Canary Tibial Extension (CTE) implant, Operating Room (OR) Base Station System ("BS1"), Home Base Station System ("BS2"), Canary Cloud Data Management Platform ("Cloud") and Canary Medical Gait Parameters (CMGP software module).
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