FDA product code OCG: Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented
OCG is the FDA product code for prosthesis, hip, pelvifemoral resurfacing, metal/polymer, uncemented. It is a Class III device, regulated under 21 CFR 888.3410 and reviewed by the Orthopedic panel. Devices under OCG reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs to be filed by 1/3/05 per 69 FR 59134 on 10/4/04 - Intended to replace the articulating surfaces of the hip while preserving the femoral head and neck and indicated for osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis of the femoral head.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented |
| Device class | Class III |
| Regulation | 21 CFR 888.3410 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for OCG devices
openFDA lists no recalls for product code OCG.
Frequently asked questions
What is FDA product code OCG?
OCG is the FDA product code for prosthesis, hip, pelvifemoral resurfacing, metal/polymer, uncemented. It is a Class III device, regulated under 21 CFR 888.3410 and reviewed by the Orthopedic panel.
What device class is OCG?
Class III, regulation 21 CFR 888.3410. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OCG
- Run a recall and safety report across every OCG manufacturer
- Watch product code OCG 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.