# K201961: IlluminOss Photodynamic Bone Stabilization System

- Pathway: 510(k) (Special)
- Applicant: Illuminoss Medical, Inc.
- Decided: Aug 13, 2020 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: 3 generations back to K960642 (1996). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081452: Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System, Synthes (Usa) (2008) Summary page 4.

## Most influential descendants
- K202887: IlluminOss Bone Stabilization System (2020), 1 descendant of its own
- K233436: IlluminOss Photodynamic Bone Stabilization System (2024), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K201961
Methodology: https://510kreport.com/methodology