canturio™te

FDA UDI

Class II (US FDA UDI)

by Canary Medical Usa Llc

Identity

Trade Name: canturio™te FDA UDI
Generic Name: Knee femur stem prosthesis FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 43-5570-058-14 FDA UDI
Description: 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860003118306 FDA UDI
510(k) Number: DEN200064 FDA UDI
FDA Product Code: QPP FDA UDI
GMDN Term: Knee femur stem prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3600 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Knee femur stem prosthesis

canturio™te by Canary Medical Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Knee femur stem prosthesis.

Endo-Model Standard Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG · Class II
Biomet Knee System — Biomet Orthopedics, Inc. · Class II
Unity Total Knee System — CORIN LTD · Class II
LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG · Class II
OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc. · Class II
Evolution Revision CCK System — MicroPort Orthopedics Inc. · Class II
Modular Stem, — WALDEMAR LINK GmbH & Co. KG · Class II
LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II

Cleared under the same submission

DEN200064 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Canary Medical Usa Llc

Sources (1)

FDA UDI 1752fac7-4284-42c4-a6c9-34281cb4042b 34 fields · synced Jun 8, 2026