QPP
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Implantable Post-Surgical Kinematic Measurement Knee Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3600
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| canturio® se (Canturio Smart Extension) (K234056) | Canary Medical USA, LLC | 2024-04-24 |
| Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System (K223803) | Canary Medical USA, LLC | 2023-03-24 |
| Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System (K220413) | Canary Medical USA, LLC | 2022-06-22 |
| Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System (DEN200064) | Canary Medical, Inc. | 2021-08-27 |
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Every clearance here is in the API, with alerts when new ones post.