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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.

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.

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.

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.

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.

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 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 postsurgery. 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 Svstem.

The Canary Tibial Extension is a physical implant component that is attached to the Zimmer Biomet Persona® tibial baseplate (K113369) to form the patient's tibial knee prosthesis. Like a traditional tibial extension, the CTE provides additional stability to the replacement knee joint. In addition, the software and electronics embedded within the CTE collect the patient's functional movement and gait parameter information post-surgery. The CTE is provided sterile via Ethylene Oxide (EtO). The CHIRP system collects unprocessed 3D accelerometer and 3D gyroscopic sensor data over the course of a day. The electronic and other unique elements incorporated within the CTE implant include an antenna, X-ray ID, printed circuit assembly, three-axis gyroscope, three-axis accelerometer, and a Lithium Carbon Mono-Fluoride (CFx) battery. The CTE with CHIRP system is composed of external base station units with embedded firmware that facilitate communication with the CTE implant. The main function of the base station units is to act as a conduit to receive and transmit encrypted raw kinematic data from the CTE to the Cloud Based software system. The Operating Room (OR) Base Station (BS1) subsystem consists of a laptop computer with the customized OR Application (OR App) software to initialize the CTE implant and record implant and procedural information, an OR base station unit, a bar code reader to incorporate TKA component and CTE serial number information, and USB cables to attach the OR base station unit and bar code reader to the computer. The Home Base Station (BS2) subsystem is located in the patient's home, is set up by the patient prior to the date of surgery, and is used to transmit patient's gait and activity information collected by the CTE. BS2 consists of a Home Base Station unit, a USB power and data cable, and a power adapter. These items are used in concert with a USB-enabled personal computer and the patient's home wireless Internet connection. The Cloud subsystem is intended to receive and store all healthcare professional (HCP) and patient data for pre-operative, day of operation, and post-operation activities, including unprocessed, patient kinematic data from the CTE implant. The post-operation processed, patient Canary Medical Gait Parameter (CMGP) data will be used by HCPs to monitor the patient's post-TKA procedure function as an adjunct to other physiological parameter measurement tools. The Cloud is accessible through a browser-based web application. Manual Instruments and Accessories: Impaction Sleeve, Canary Tibia Cut Guide (5 DEGREE - L/R), Canary Drill Bit, CTE Provisional, CTE Template.