FDA product code KWR: Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented
KWR is the FDA product code for prosthesis, shoulder, constrained, metal/metal or metal/polymer cemented. It is a Class III device, regulated under 21 CFR 888.3640 and reviewed by the Orthopedic panel. Devices under KWR reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for KWR devices.
Definition
Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented |
| Device class | Class III |
| Regulation | 21 CFR 888.3640 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for KWR devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-11-28.
Frequently asked questions
What is FDA product code KWR?
KWR is the FDA product code for prosthesis, shoulder, constrained, metal/metal or metal/polymer cemented. It is a Class III device, regulated under 21 CFR 888.3640 and reviewed by the Orthopedic panel.
What device class is KWR?
Class III, regulation 21 CFR 888.3640. Typical premarket route: PMA.
Have KWR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-11-28.
Next steps
- Run an FDA pathway report with predicate devices for product code KWR
- Run a recall and safety report across every KWR manufacturer
- Watch product code KWR 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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