QPP — Implantable Post-Surgical Kinematic Measurement Knee Device Class II
Classification Details
- Product Code
- QPP
- Device Class
- Class II
- Regulation Number
- 888.3600
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K234056 | canary medical usa | canturio® se (Canturio Smart Extension) | April 24, 2024 |
| K223803 | canary medical usa | Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor ( | March 24, 2023 |
| K220413 | canary medical usa | Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor ( | June 22, 2022 |
| DEN200064 | canary medical | Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) | August 27, 2021 |