510(k) · Cleared
ClearedIlluminOss Photodynamic 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 Jan 19, 2024 as substantially equivalent to K202887 (Illuminoss Medical, Inc., 2020) after a 98-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Jan 19, 2024
- Review
- 98 days
- Class
- Class II
- Product code
- QAD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K960642 (1996). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK960642 Nancy NailLandos, Inc. · 1996
- 4 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
- 3 generations backK081452 Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008
- 2 generations backK201961 IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc. · 2020
- 1 generation backK202887 IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc. · 2020
- This deviceK233436 IlluminOss Photodynamic Bone Stabilization SystemIlluminoss Medical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960642 | Nancy Nail | Landos, Inc. | 1996 | — |
| −4 | K971783 | Synthes Elastic Intramedullary Nail (Ein) System | Synthes (Usa) | 1997 | — |
| −3 | K081452 | Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System | Synthes (Usa) | 2008 | — |
| −2 | K201961 | IlluminOss Photodynamic Bone Stabilization System | Illuminoss Medical, Inc. | 2020 | — |
| −1 | K202887 | IlluminOss Bone Stabilization System | Illuminoss Medical, Inc. | 2020 | — |
| 0 (this device) | K233436 | IlluminOss Photodynamic Bone Stabilization System | Illuminoss Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) 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 K202887 IlluminOss Bone Stabilization Systemscore 4.1 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K202887 | IlluminOss Bone Stabilization SystemSummary page 4…Class II Product Code: QAD (Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light Activated) Predicate Device: K202887 - IlluminOss Photodynamic Bone Stabilization System. Indications for Use: The IlluminOss Photodynamic Bone Stabilization System… | 2020 |
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.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
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. 2024, 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?
The IlluminOss Photodynamic Bone Stabilization System is indicated for use in skeletally mature patients in the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, ulna, clavicle, pelvis, fibula, metacarpals, metatarsals, and phalanges. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with FDA-cleared fracture fixation systems to provide supplemental fixation in these anatomic sites. The IlluminOss System may be used in the femur and tibia to provide supplemental fixation to an anatomically appropriate FDA-cleared fracture fixation system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233436 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233436: IlluminOss Photodynamic Bone Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233436
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026