canturio™te

GUDID 00860003118306

The canturio te (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 during 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.

Canary Medical USA LLC

Knee femur stem prosthesis

• Primary Device ID: 00860003118306
• NIH Device Record Key: 1752fac7-4284-42c4-a6c9-34281cb4042b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: canturio™te
• Version Model Number: 43-5570-058-14
• Company DUNS: 117153396
• Company Name: Canary Medical USA LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003118306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200064

FDA Product Code

• QPP: Implantable Post-Surgical Kinematic Measurement Knee Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-30
• Device Publish Date: 2021-09-22

Devices Manufactured by Canary Medical USA LLC

• 00860003118399 - Canturio® Smart Extension 14mm (D) x 30mm (H): 2024-09-20 Canturio® Smart Extension 14mm (D) x 30mm (H) with Canary Health Implanted Reporting Processor (CHIRP®) system is a tibial ext
• 00850015699153 - Home Base Station (Bluetooth): 2024-09-16 The Canary Home Base Station (Bluetooth) subsystem is a unit with embedded firmware that facilitate communication with CTE and C
• 00850015699115 - CanarE Strap: 2023-05-25
• 00850015699122 - Canary Clinic Cart: 2023-05-25
• 00850015699139 - CanarE Charging Cradle: 2023-05-25
• 00860003118344 - CanarE – Clinic Wearable Device: 2023-05-25
• 00860003118368 - Canary Clinic Base Station: 2023-05-25
• 00860003118382 - Clinic Laptop: 2023-05-25