FDA product code PPQ: Transtibial Anterior Cruciate Ligament Kit
PPQ is the FDA product code for transtibial anterior cruciate ligament kit. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel. Devices under PPQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Transtibial Anterior Cruciate Ligament Kit |
| Device class | Class II |
| Regulation | 21 CFR 888.3040 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Recalls for PPQ devices
openFDA lists no recalls for product code PPQ.
Frequently asked questions
What is FDA product code PPQ?
PPQ is the FDA product code for transtibial anterior cruciate ligament kit. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel.
What device class is PPQ?
Class II, regulation 21 CFR 888.3040. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PPQ
- Run a recall and safety report across every PPQ manufacturer
- Watch product code PPQ 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.