FDA product code KXB: Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer
KXB is the FDA product code for prosthesis, hip, pelvifemoral resurfacing, metal/polymer. It is a Class III device, regulated under 21 CFR 888.3410 and reviewed by the Orthopedic panel. Devices under KXB reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 3 recalls for KXB devices, 3 initiated in the last five years.
Definition
Pma to be filed by 1/3/05 (69 fr 59134 (10/4/04)) for any hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976, or that has, on or before january 3, 2005, been found to be substantially equivalent to a hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976. Any other hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis must have an approved pma or a declared completed pdp in effect before being placed in commercial distribution.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer |
| Device class | Class III |
| Regulation | 21 CFR 888.3410 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for KXB devices
3 product recalls in 1 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2023-05-30.
| Year | Recalls |
|---|---|
| 2023 | 3 |
Frequently asked questions
What is FDA product code KXB?
KXB is the FDA product code for prosthesis, hip, pelvifemoral resurfacing, metal/polymer. It is a Class III device, regulated under 21 CFR 888.3410 and reviewed by the Orthopedic panel.
What device class is KXB?
Class III, regulation 21 CFR 888.3410. Typical premarket route: PMA.
Have KXB devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2023-05-30.
Next steps
- Run an FDA pathway report with predicate devices for product code KXB
- Run a recall and safety report across every KXB manufacturer
- Watch product code KXB 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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