Implantable Post-Surgical Kinematic Measurement Knee Device
QPP is the FDA product code for Implantable Post-Surgical Kinematic Measurement Knee Device, a class II device type, regulated under 21 CFR 888.3600. FDA's definition for this code reads: "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...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- QPP
- Device name
- Implantable Post-Surgical Kinematic Measurement Knee Device
- 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.
- Regulation
- 21 CFR 888.3600
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 1
Clearances, product code QPP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code QPP| Applicant | Clearances |
|---|---|
| Canary Medical USA LLC | 4 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
