FDA product code KXD: Prosthesis, Hip, Constrained, Metal
KXD is the FDA product code for prosthesis, hip, constrained, metal. It is a Class III device, regulated under 21 CFR 888.3300 and reviewed by the Orthopedic panel. Devices under KXD reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs 12/26/96 (61 FR 50709 (9/27/96))
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Constrained, Metal |
| Device class | Class III |
| Regulation | 21 CFR 888.3300 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for KXD devices
openFDA lists no recalls for product code KXD.
Frequently asked questions
What is FDA product code KXD?
KXD is the FDA product code for prosthesis, hip, constrained, metal. It is a Class III device, regulated under 21 CFR 888.3300 and reviewed by the Orthopedic panel.
What device class is KXD?
Class III, regulation 21 CFR 888.3300. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code KXD
- Run a recall and safety report across every KXD manufacturer
- Watch product code KXD 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times