FDA product code KWB: Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal
KWB is the FDA product code for prosthesis, hip, hemi-, acetabular, cemented, metal. It is a Class III device, regulated under 21 CFR 888.3370 and reviewed by the Orthopedic panel. Devices under KWB reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs 12/26/96 (61 FR 50710 (9/27/96))
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal |
| Device class | Class III |
| Regulation | 21 CFR 888.3370 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for KWB devices
openFDA lists no recalls for product code KWB.
Frequently asked questions
What is FDA product code KWB?
KWB is the FDA product code for prosthesis, hip, hemi-, acetabular, cemented, metal. It is a Class III device, regulated under 21 CFR 888.3370 and reviewed by the Orthopedic panel.
What device class is KWB?
Class III, regulation 21 CFR 888.3370. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code KWB
- Run a recall and safety report across every KWB manufacturer
- Watch product code KWB 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.