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 Jun 25, 2020 as substantially equivalent to K180050 (Curvafix, Inc., 2019) and 3 other predicates after a 141-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Jun 25, 2020
- Review
- 141 days
- Class
- Class II
- Product code
- QAD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K903258 (1990). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK903258 Hagie PinOnyx Medical Corp. · 1990
- 2 generations backK991649 Depuy Rockwood Clavicle PinDepuy, Inc. · 1999
- 1 generation backK103001 Rockwood Clavicle PinsDePuy Orthopaedics, Inc. · 2011
- This deviceK200295 IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903258 | Hagie Pin | Onyx Medical Corp. | 1990 | — |
| −2 | K991649 | Depuy Rockwood Clavicle Pin | Depuy, Inc. | 1999 | — |
| −1 | K103001 | Rockwood Clavicle Pins | DePuy Orthopaedics, Inc. | 2011 | — |
| 0 (this device) | K200295 | IlluminOss Bone Stabilization System | Illuminoss Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2019 | 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 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? (4)
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 |
|---|---|---|---|
| * | K180050 | CurvaFix Intramedullary Rodscrew SystemSummary page 4…icate Device: The modified IlluminOss Photodynamic Bone Stabilization System is substantially equivalent to the predicate CurvaFix, Inc. Intramedullary Rod Screw System (K180050), Synthes (USA) Low Profile Reconstruction Plates (K042377), DePuy Orthopaedics, Inc. Rockwood Clavicle Pin (K103001), and Small… | 2019 |
| * | K042377 | Synthes Low Profile Reconstruction PlatesSummary page 4…bilization System is substantially equivalent to the predicate CurvaFix, Inc. Intramedullary Rod Screw System (K180050), Synthes (USA) Low Profile Reconstruction Plates (K042377), DePuy Orthopaedics, Inc. Rockwood Clavicle Pin (K103001), and Small Bone Innovations, Inc. MetaFLEX IM Nail System (K051605) wi… | 2004 |
| * | K103001 | Rockwood Clavicle PinsSummary page 4…cate CurvaFix, Inc. Intramedullary Rod Screw System (K180050), Synthes (USA) Low Profile Reconstruction Plates (K042377), DePuy Orthopaedics, Inc. Rockwood Clavicle Pin (K103001), and Small Bone Innovations, Inc. MetaFLEX IM Nail System (K051605) with respect to intended use, indications for use, technolog… | 2011 |
| * | K051605 | Sbi K-WiresSummary page 4…es (USA) Low Profile Reconstruction Plates (K042377), DePuy Orthopaedics, Inc. Rockwood Clavicle Pin (K103001), and Small Bone Innovations, Inc. MetaFLEX IM Nail System (K051605) with respect to intended use, indications for use, technological characteristics, and performance data. The previously cleared I… | 2005 |
| † | K183145 | IlluminOss Photodynamic Bone Stabilization System | 2018 |
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 30 years and passes through 4 companies; a new generation was cleared every 9.4 years on median.
- None of the 9 ancestors has a recall.
- 2 other devices also cite its predicate K180050.
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. 2020, 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, and ulna. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with an FDA-cleared fracture fixation system to provide supplemental fixation in the humerus, radius, and ulna. It is also indicated for use in skeletally mature patients in the treatment of fractures of the pelvis, clavicle, metacarpals, metatarsals, and phalanges.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200295: 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/K200295
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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