FDA product code QPP: Implantable Post-Surgical Kinematic Measurement Knee Device
QPP is the FDA product code for implantable post-surgical kinematic measurement knee device. It is a Class II device, regulated under 21 CFR 888.3600 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under QPP, 3 in the last five years. The average 510(k) review took 116 days (median 124); 124 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for QPP devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Implantable Post-Surgical Kinematic Measurement Knee Device |
| Device class | Class II |
| Regulation | 21 CFR 888.3600 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for QPP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 128 |
| 2023 | 1 | 95 |
| 2024 | 1 | 124 |
Compare with all 510(k) review times · Search every QPP clearance
Top QPP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Canary Medical USA, LLC | 3 | 2024-04-24 |
Most recent QPP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K234056 | Canary Medical USA, LLC | canturio® se (Canturio Smart Extension) | 2024-04-24 | 124 |
| K223803 | Canary Medical USA, LLC | Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System | 2023-03-24 | 95 |
| K220413 | Canary Medical USA, LLC | Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System | 2022-06-22 | 128 |
Recalls for QPP devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-05-02.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code QPP?
QPP is the FDA product code for implantable post-surgical kinematic measurement knee device. It is a Class II device, regulated under 21 CFR 888.3600 and reviewed by the Orthopedic panel.
What device class is QPP?
Class II, regulation 21 CFR 888.3600. Typical premarket route: 510(k).
How long does a 510(k) take for product code QPP?
Across 3 cleared submissions the average was 116 days from receipt to decision (median 124).
Which companies have the most QPP clearances?
Canary Medical USA, LLC (3).
Have QPP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-05-02.
Next steps
- Run an FDA pathway report with predicate devices for product code QPP
- Run a recall and safety report across every QPP manufacturer
- Watch product code QPP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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