FDA product code HRZ: Prosthesis, Knee, Hinged (Metal-Metal)
HRZ is the FDA product code for prosthesis, knee, hinged (metal-metal). It is a Class III device, regulated under 21 CFR 888.3480 and reviewed by the Orthopedic panel. Devices under HRZ reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
PMAs to be filed by 12/26/96 (61 FR 50710 (9/27/96))
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Hinged (Metal-Metal) |
| Device class | Class III |
| Regulation | 21 CFR 888.3480 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for HRZ devices
openFDA lists no recalls for product code HRZ.
Frequently asked questions
What is FDA product code HRZ?
HRZ is the FDA product code for prosthesis, knee, hinged (metal-metal). It is a Class III device, regulated under 21 CFR 888.3480 and reviewed by the Orthopedic panel.
What device class is HRZ?
Class III, regulation 21 CFR 888.3480. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code HRZ
- Run a recall and safety report across every HRZ manufacturer
- Watch product code HRZ 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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