FDA product code QAD: Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
QAD is the FDA product code for rod, fixation, intramedullary and accessories, in-vivo cured, light-activated. It is a Class II device, regulated under 21 CFR 888.3023 and reviewed by the Orthopedic panel. FDA has cleared 6 510(k) submissions under QAD, 1 in the last five years. The average 510(k) review took 74 days (median 64); 98 days on average over the last three years. 1 De Novo request was granted under it.
Definition
Is a device intended to be implanted that consists of a polymeric balloon that is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. The balloon is infused with a liquid monomer that causes the balloon to fill the medullary canal of the fractured bone. The device is then exposed to a light source that polymerizes the light-activated monomer within the balloon creating a hardened rigid structure.
Classification
| Field | Value |
|---|---|
| Device name | Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated |
| Device class | Class II |
| Regulation | 21 CFR 888.3023 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for QAD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 72 |
| 2020 | 3 | 67 |
| 2024 | 1 | 98 |
Compare with all 510(k) review times · Search every QAD clearance
Top QAD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Illuminoss Medical, Inc. | 6 | 2024-01-19 |
Most recent QAD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233436 | Illuminoss Medical, Inc. | IlluminOss Photodynamic Bone Stabilization System | 2024-01-19 | 98 |
| K202887 | Illuminoss Medical, Inc. | IlluminOss Bone Stabilization System | 2020-10-27 | 29 |
| K201961 | Illuminoss Medical, Inc. | IlluminOss Photodynamic Bone Stabilization System | 2020-08-13 | 30 |
| K200295 | Illuminoss Medical, Inc. | IlluminOss Bone Stabilization System | 2020-06-25 | 141 |
| K183145 | Illuminoss Medical, Inc. | IlluminOss Photodynamic Bone Stabilization System | 2018-12-13 | 30 |
Recalls for QAD devices
openFDA lists no recalls for product code QAD.
Frequently asked questions
What is FDA product code QAD?
QAD is the FDA product code for rod, fixation, intramedullary and accessories, in-vivo cured, light-activated. It is a Class II device, regulated under 21 CFR 888.3023 and reviewed by the Orthopedic panel.
What device class is QAD?
Class II, regulation 21 CFR 888.3023. Typical premarket route: 510(k).
How long does a 510(k) take for product code QAD?
Across 6 cleared submissions the average was 74 days from receipt to decision (median 64).
Which companies have the most QAD clearances?
Illuminoss Medical, Inc. (6).
Next steps
- Run an FDA pathway report with predicate devices for product code QAD
- Run a recall and safety report across every QAD manufacturer
- Watch product code QAD 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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