Cleared Traditional

K234056 - canturio® se (Canturio Smart Extension) (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K234056 · Canary Medical USA, LLC · Orthopedic device
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Apr 2024
Decision
124d
Days
Class 2
Risk

K234056 is an FDA 510(k) clearance for the canturio® se (Canturio Smart Extension). Classified as Implantable Post-surgical Kinematic Measurement Knee Device (product code QPP), Class II - Special Controls.

Submitted by Canary Medical USA, LLC (Carlsbad, US). The FDA issued a Cleared decision on April 24, 2024 after a review of 124 days - within the typical 510(k) review window.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Canary Medical USA, LLC devices

Submission Details

510(k) Number K234056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2023
Decision Date April 24, 2024
Days to Decision 124 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 122d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Devices cleared under the same product code (QPP) and FDA review panel - the closest regulatory comparables to K234056.
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
K223803 · Canary Medical USA, LLC · Mar 2023
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
K220413 · Canary Medical USA, LLC · Jun 2022
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DEN200064 · Canary Medical, Inc. · Aug 2021