Product code QPP— Orthopedic
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
- Classification name
- Implantable Post-Surgical Kinematic Measurement Knee Device
- Device class
- Class 2
- Regulation
- 21 CFR 888.3600
- Advisory panel
- Orthopedic
- Total cleared
- 4
- First cleared
- Most recent
FDA classification definition
“An implantable post-surgical kinematic measurement knee device is a device that provides objective kinematic data after total knee arthroplasty surgery. The kinematic data provided by the device are used as an adjunct to other physiological parameter measurement tools utilized during the course of patient monitoring and treatment post-surgery.”
Market context for product code QPP
FDA has cleared devices under product code QPP between 2021 and 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2024
- 2023
- 2022
- 2021
Top applicants under product code QPP
Recent clearances under product code QPP
- K234056 — canturio® se (Canturio Smart Extension)
- K223803 — Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
- K220413 — Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
- DEN200064 — Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System
Data sourced from openFDA. This site is unofficial and independent of the FDA.