510(k) · Cleared
ClearedIlluminOss Bone Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Illuminoss Medical, Inc. · QAD Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
Cleared on Aug 31, 2018 after a 115-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Aug 31, 2018
- Review
- 115 days
- Class
- Class II
- Product code
- QAD
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK181228 IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK183145 IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K183145IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K181228 | IlluminOss Bone Stabilization System | Illuminoss Medical, Inc. | 2018 | — |
| +1 | K183145 | IlluminOss Photodynamic Bone Stabilization System | Illuminoss Medical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183145 | IlluminOss Photodynamic Bone Stabilization System | 2018 | 0 |
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.
What does this lineage say?
- Of its descendants, K183145 (Illuminoss Medical, Inc., 2018) has gone furthest, with 0 descendants of its own.
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. 2018, 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 | — |
https://510kreport.com/device/K181228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181228: IlluminOss Bone Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181228
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026