K220413 is an FDA 510(k) clearance for the Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System. This device is classified as a Implantable Post-surgical Kinematic Measurement Knee Device (Class II - Special Controls, product code QPP).
Submitted by Canary Medical USA, LLC (Carlsbad, US). The FDA issued a Cleared decision on June 22, 2022, 128 days after receiving the submission on February 14, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3600. 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..
| 510(k) Number | K220413 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2022 |
| Decision Date | June 22, 2022 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | QPP - Implantable Post-surgical Kinematic Measurement Knee Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3600 |
| 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. |