# K233436: IlluminOss Photodynamic Bone Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Illuminoss Medical, Inc.
- Decided: Jan 19, 2024 after 98 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: 5 generations back to K960642 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202887: IlluminOss Bone Stabilization System, Illuminoss Medical, Inc. (2020) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K233436
Methodology: https://510kreport.com/methodology