# DEN200064: Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System

- Pathway: De Novo (Direct)
- Applicant: Canary Medical, Inc.
- Decided: Aug 27, 2021 after 312 days
- Product code: QPP (Implantable Post-Surgical Kinematic Measurement Knee Device)
- Device class: 2
- Regulation: 21 CFR 888.3600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K234056: canturio® se (Canturio Smart Extension) (2024), 0 descendants of its own
- K223803: Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System (2023), 0 descendants of its own
- K220413: Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System (2022), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN200064
Methodology: https://510kreport.com/methodology