Canary Tibial Extension (CTE) With Canary Health Implanted Reporting Processor (CHIRP) System
Canary Medical USA LLC
CANARY MEDICAL USA LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015802419 | 3015802419 | CANARY MEDICAL USA LLC | 1 | N | 2026-01-01 | 2710 Loker Ave. West, Suite 350 Carlsbad CA US 92010 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 295064 | 1778205830 | K234056 | canturio® se (Canturio Smart Extension) | QPP | 2024-04-24 |
| 295064 | 1100804150 | DEN200064 | Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System | QPP | 2021-08-27 |
| 295064 | 1521121816 | ||||
| 295064 | 1686183194 | ||||
| 295064 | 1851226246 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QPP | 2 | 2024-04-24 |
PMN#
GUDID#
Canary Flight Plan - v.1.0.0
2026-08-07
Canary Recovery Curve - v.1.1
2026-08-07
CanarE Strap - 43-5570-007-16
2023-05-17
canturio™te Impaction Sleeve - The Impaction Sleeve is a reusable (provided non-sterile), surgical instrument used to assist in attaching the CTE implant to the Zimmer Biomet Persona® Tibial Baseplate. The Impaction Sleeve protects the implant’s electronic components from impaction forces that occur during assembly.
2021-09-22
Canturio® Smart Extension 14mm (D) x 30mm (H) - Canturio® Smart Extension 14mm (D) x 30mm (H) with Canary Health Implanted Reporting Processor (CHIRP®) system is a tibial extension implant containing electronicsand software.
2024-09-12
Home Base Station (Bluetooth) - The Canary Home Base Station (Bluetooth) subsystem is a unit with embedded firmware that facilitate communication with CTE and CSE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient.
2024-09-06
Canary Clinic Cart - 43-5570-008-14
2023-05-17
CanarE Charging Cradle - 43-5570-007-15
2023-05-17
CanarE – Clinic Wearable Device - 43-5570-007-14
2023-05-17
Canary Clinic Base Station - 43-5570-005-14
2023-05-17
Clinic Laptop - 43-5570-003-15
2023-05-17
canturio™te Cemented Tibia Drill Bit - The Canary Medical Drill Bit is used to create the cavity in the patient’s tibial intramedullary canal to fit the CTE implant and cement mantle.
2021-09-22
canturio™te Tibia Resection Cutting Guide, Left, 5 Deg. - The Canary Medical Tibia Resection Cutting Guide (left or right option) is used for tibia preparation when implanting a Persona® Primary Knee with a Canary Medical Tibial Extension (CTE) Implant.
2021-09-22
canturio™te Tibia Resection Cutting Guide, Right, 5 Deg. - The Canary Medical Tibia Resection Cutting Guide (left or right option) is used for tibia preparation when implanting a Persona® Primary Knee with a Canary Medical Tibial Extension (CTE) Implant.
2021-09-22
canturio™te Modular Bracket Stem Provisional - Stem provisional is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves.
2021-09-22
canturio™te Modular Bracket Drill Bit - Drill Bit is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves.
2021-09-22
canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg. - Tibial Cutting guide is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves.
2021-09-22
canturio™te Modular Bracket Tibial Cutting Guide, Right; 5 Deg. - Tibial Cutting guide is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves.
2021-09-22
canturio™ te Modular Bracket, Impaction Sleeve - CTE Instruments are stored in an Instrument Tray which has no contact with the patient. Within the tray, the Instruments are held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves.
2021-09-22
canturio™te Provisional - The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Medical Tibial Extension adds 58 mm to the length of the tibial keel nominally when assembled. This CTE Provisional is used to ensure the fit of the CTE implant within the patient’s anatomy prior to CTE implantation.
2021-09-22
Canary OR Base Station / OR PC App / OR Registration - The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
2021-09-22
Canary Home Base Station - The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that facilitate communication with the CTE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient.
2021-09-22
OR Barcode Scanner - After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other implanted TKA components.
2021-09-29
OR Laptop - Dedicated Laptop PC, part of the OR Base Station System
2021-09-29
canturio™te Canary Tibial Ext 14x58mm X-Ray Template - The CTE 14mm x 58mm X-Ray Template is a surgical instrument used to assist the surgeon during preoperative planning.
2021-09-22
canturio™te - 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.
2021-09-22