FDA product code PJY: Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
PJY is the FDA product code for osseoanchored prostheses for the rehabilitation of transfemoral amputees. It is a Class III device, reviewed by the Orthopedic panel. Devices under PJY reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
The device is a percutaneous prosthetic device for the direct skeletal attachment of a prosthetic limb.
Classification
| Field | Value |
|---|---|
| Device name | Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for PJY devices
openFDA lists no recalls for product code PJY.
Frequently asked questions
What is FDA product code PJY?
PJY is the FDA product code for osseoanchored prostheses for the rehabilitation of transfemoral amputees. It is a Class III device, reviewed by the Orthopedic panel.
What device class is PJY?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code PJY
- Run a recall and safety report across every PJY manufacturer
- Watch product code PJY 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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