De Novo · Granted
GrantedIlluminOss Bone Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Illminoss Medical, Inc. · QAD Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
Granted on Dec 19, 2017 as a new device type through De Novo after a 356-day review.
- Decided
- Dec 19, 2017
- Review
- 356 days
- Class
- Class II
- Product code
- QAD
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QAD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QAD device
- #1 K233436 IlluminOss Photodynamic Bone Stabilization…score 7.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QAD devicesQAD Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · QAD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QAD
30in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QAD
No recall names QAD since 2007.
Adverse event reports per year · QAD
21in 2025
MAUDE reports naming product code QAD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 3 | 30 | 0 | 7 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 25 |
| 2023 | 0 | — | 0 | 47 |
| 2024 | 1 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 21 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
IlluminOss Photodynamic Bone Stabilization System (PBSS) is indicated for skeletally mature patients in the treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN160062 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN160062: IlluminOss Bone Stabilization System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN160062
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026