# K183145: IlluminOss Photodynamic Bone Stabilization System

- Pathway: 510(k) (Special)
- Applicant: Illuminoss Medical, Inc.
- Decided: Dec 13, 2018 after 30 days
- Product code: QAD (Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated)
- Device class: 2
- Regulation: 21 CFR 888.3023
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K181228 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181228: IlluminOss Bone Stabilization System, Illuminoss Medical, Inc. (2018) Summary page 4.

## Indications for use
IlluminOss Photodynamic Bone Stabilization System (PBSS) 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.

Source page: https://510kreport.com/device/K183145
Methodology: https://510kreport.com/methodology