# DEN160062: IlluminOss Bone Stabilization System

- Pathway: De Novo (Direct)
- Applicant: Illminoss Medical, Inc.
- Decided: Dec 19, 2017 after 356 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
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.

Source page: https://510kreport.com/device/DEN160062
Methodology: https://510kreport.com/methodology