QPP
- Product code
- QPP
- Device name
- Implantable Post-Surgical Kinematic Measurement Knee Device
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3600
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 4
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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K234056 | 2024-04-24 | Canary Medical USA, LLC | canturio® se (Canturio Smart Extension) |
Official FDA classification page: QPP
Classification and pathway per current FDA publications. Data from openFDA (CC0).