510(k) · Cleared
ClearedCanary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canary Medical USA, LLC · QPP Implantable Post-Surgical Kinematic Measurement Knee Device
Cleared on Mar 24, 2023 as substantially equivalent to DEN200064 (Canary Medical, Inc., 2021) after a 95-day review. Its family tree reaches back 1 generation to 2021.
- Decided
- Mar 24, 2023
- Review
- 95 days
- Class
- Class II
- Product code
- QPP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200064 (2021). No later device cites it as a predicate yet.
- Root · 1 generation backDEN200064 Canary Tibial Extension with Canary Health Implanted Reporting…Canary Medical, Inc. · 2021
- This deviceK223803 Canary Tibial Extension (CTE) with Canary Health Implanted Reporting…Canary Medical USA, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200064 | Canary Tibial Extension with Canary Health Implanted Reporting Processor… | Canary Medical, Inc. | 2021 | — |
| 0 (this device) | K223803 | Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor… | Canary Medical USA, LLC | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QPP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QPP device
- #1 K234056 canturio® se (Canturio Smart Extension)score 5.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN200064 | Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) SystemSummary page 4…PP Device Class: II Predicate Device: Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System (DEN200064) Device Description: The Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN200064.
How does its category compare?
All QPP devicesQPP Implantable Post-Surgical Kinematic Measurement Knee Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QPP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QPP
Too few QPP 510(k)s in any year since 2007 to give a median.
Recalls per year · QPP
No recall names QPP since 2007.
Adverse event reports per year · QPP
1in 2024
MAUDE reports naming product code QPP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Canary Tibial Extension (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 by the physician during patient monitoring and treatment post-surgery. The device is indicated for use…
Read the full statement (125 words)
The Canary Tibial Extension (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 by the physician during 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223803: Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223803
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026