QAD
7 FDA 510(k) clearances · Product code
98 daysmedian time to decision
356 days90th percentile
7clearances measured
FDA profile
- Official device name
- Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3023
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA 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.
- Adverse events (MAUDE)
- 2022: 25 · 2023: 47 · 2024: 34 · 2025: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IlluminOss Photodynamic Bone Stabilization System (K233436) | Illuminoss Medical, Inc. | 2024-01-19 |
| IlluminOss Bone Stabilization System (K202887) | Illuminoss Medical, Inc. | 2020-10-27 |
| IlluminOss Photodynamic Bone Stabilization System (K201961) | Illuminoss Medical, Inc. | 2020-08-13 |
| IlluminOss Bone Stabilization System (K200295) | Illuminoss Medical, Inc. | 2020-06-25 |
| IlluminOss Photodynamic Bone Stabilization System (K183145) | Illuminoss Medical, Inc. | 2018-12-13 |
| IlluminOss Bone Stabilization System (K181228) | Illuminoss Medical, Inc. | 2018-08-31 |
| IlluminOss Bone Stabilization System (DEN160062) | Illminoss Medical, Inc. | 2017-12-19 |
Track QAD automatically
Every clearance here is in the API, with alerts when new ones post.