# K234056: canturio® se (Canturio Smart Extension)

- Pathway: 510(k) (Traditional)
- Applicant: Canary Medical USA, LLC
- Decided: Apr 24, 2024 after 124 days
- Product code: QPP (Implantable Post-Surgical Kinematic Measurement Knee Device)
- Device class: 2
- Regulation: 21 CFR 888.3600
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN200064 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200064: Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System, Canary Medical, Inc. (2021) Summary page 4.

## Recalls of this device
- May 2, 2025 · Class II · Z-2099-2025: Due to labeling error. Product incorrectly labeled.

## Indications for use
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.

Source page: https://510kreport.com/device/K234056
Methodology: https://510kreport.com/methodology