De Novo · Granted
GrantedCanary Tibial Extension 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, Inc. · QPP Implantable Post-Surgical Kinematic Measurement Knee Device
Granted on Aug 27, 2021 as a new device type through De Novo after a 312-day review. 3 later devices descend from it.
- Decided
- Aug 27, 2021
- Review
- 312 days
- Class
- Class II
- Product code
- QPP
- Recalls
- None
3 later devices descend from it, 3 citing it directly.
- This deviceDEN200064 Canary Tibial Extension with Canary Health Implanted Reporting…Canary Medical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK234056 canturio® se (Canturio Smart Extension)Canary Medical USA, LLC · 2024 · Recalled
- Descendant · cites it directly · 0 of its ownK223803 Canary Tibial Extension (CTE) with Canary Health Implanted Reporting…Canary Medical USA, LLC · 2023
- Descendant · cites it directly · 0 of its ownK220413 Canary Tibial Extension (CTE) with Canary Health Implanted Reporting…Canary Medical USA, LLC · 2022
Most influential descendants
Showing 3 of 3 · See all- K234056canturio® se (Canturio Smart Extension)Canary Medical USA, LLC · 2024 · cites it directly0descendants
- K223803Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP)…Canary Medical USA, LLC · 2023 · cites it directly0descendants
- K220413Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP)…Canary Medical USA, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200064 | Canary Tibial Extension with Canary Health Implanted Reporting Processor… | Canary Medical, Inc. | 2021 | — |
| +1 | K234056 | canturio® se (Canturio Smart Extension) | Canary Medical USA, LLC | 2024 | 1 |
| +1 | K223803 | Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor… | Canary Medical USA, LLC | 2023 | — |
| +1 | K220413 | Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor… | Canary Medical USA, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA De Novo 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
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K234056 (Canary Medical USA, LLC, 2024) has gone furthest, with 0 descendants of its own.
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. 2021, 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 the course of patient monitoring and treatment post-surgery. The device is…
Read the full statement (128 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200064 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN200064: Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN200064
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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