Not Cleared Direct

DEN200064 - Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN200064 · Canary Medical, Inc. · Orthopedic device
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Aug 2021
Decision
312d
Days
Class 2
Risk

DEN200064 is an FDA 510(k) submission (not cleared) for the Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHI.... Classified as Implantable Post-surgical Kinematic Measurement Knee Device (product code QPP), Class II - Special Controls.

Submitted by Canary Medical, Inc. (Vancouver, CA). The FDA issued a Not Cleared (DENG) decision on August 27, 2021 after a review of 312 days.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3600 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 312 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Canary Medical, Inc. devices

Submission Details

510(k) Number DEN200064 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 19, 2020
Decision Date August 27, 2021
Days to Decision 312 days
Submission Type Direct
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 122d · This submission: 312d
Pathway characteristics

Device Classification

Product Code QPP Implantable Post-surgical Kinematic Measurement Knee Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3600
Definition An Implantable Post-surgical Kinematic Measurement Knee Device Is A Device That Provides Objective Kinematic Data After Total Knee Arthroplasty Surgery. The Kinematic Data Provided By The Device Are Used As An Adjunct To Other Physiological Parameter Measurement Tools Utilized During The Course Of Patient Monitoring And Treatment Post-surgery.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - QPP Implantable Post-surgical Kinematic Measurement Knee Device

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