510(k) · Cleared
Recalled · Class II · 2025canturio® se (Canturio Smart Extension)
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 Apr 24, 2024 as substantially equivalent to DEN200064 (Canary Medical, Inc., 2021) after a 124-day review. Its family tree reaches back 1 generation to 2021. It has been recalled once.
- Decided
- Apr 24, 2024
- Review
- 124 days
- Class
- Class II
- Product code
- QPP
- Recalls
- 1
- 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 deviceK234056 canturio® se (Canturio Smart Extension)Canary Medical USA, LLC · 2024
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) | K234056 | canturio® se (Canturio Smart Extension) | Canary Medical USA, LLC | 2024 | — |
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 K223803 Canary Tibial Extension (CTE) with Canary…score 5.1 · 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…ŝĐĞůĂƐƐ͗ II WƌĞĚŝĐĂƚĞĞǀŝĐĞ͗ Canary Tibial Extension (CTE) with Canary Health Implanted ZĞƉŽƌƟŶŐ Processor (CHIRP) System (DEN200064) WƵƌƉŽƐĞŽĨ^ƵďŵŝƐƐŝŽŶ͗ The purpose of this submission is to seek 510(k) clearance for the canturio® s… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 2, 2025 | Class II | Z-2099-2025 | Process change control | Due to labeling error. Product incorrectly labeled. |
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. 2024, 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 canturio® se (Canturio Smart Extension) 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…
Read the full statement (128 words)
The canturio® se (Canturio Smart Extension) 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 30mm sized tibial stem extension.
The objective kinematic data generated by the canturio® se with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit.
The canturio® se with CHIRP System is compatible with Zimmer Persona® Personalized Knee System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234056 · printed Nov 5, 2026
Cite this page
510(k) Report. “K234056: canturio® se (Canturio Smart Extension).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K234056
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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