FDA product code OKD: Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde, Long Bone Nonunion
OKD is the FDA product code for filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde, long bone nonunion. It is a HDE device, reviewed by the Orthopedic panel. Devices under OKD reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
Bone graft substitute when autograft is unavailable or unfeasible to harvest for treatment of recalcitrant long bone non-unions where normal bone metabolism and healing is not present, e.g., smokers and diabetics.
Classification
| Field | Value |
|---|---|
| Device name | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde, Long Bone Nonunion |
| Device class | HDE |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for OKD devices
openFDA lists no recalls for product code OKD.
Frequently asked questions
What is FDA product code OKD?
OKD is the FDA product code for filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde, long bone nonunion. It is a HDE device, reviewed by the Orthopedic panel.
What device class is OKD?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code OKD
- Run a recall and safety report across every OKD manufacturer
- Watch product code OKD 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.