# K200295: IlluminOss Bone Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Illuminoss Medical, Inc.
- Decided: Jun 25, 2020 after 141 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 K903258 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180050: CurvaFix Intramedullary Rodscrew System, Curvafix, Inc. (2019) Summary page 4.
- K042377: Synthes Low Profile Reconstruction Plates, Synthes (Usa) (2004) Summary page 4.
- K103001: Rockwood Clavicle Pins, DePuy Orthopaedics, Inc. (2011) Summary page 4.
- K051605: Sbi K-Wires, Small Bone Innovations, LLC (2005) 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, 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.

Source page: https://510kreport.com/device/K200295
Methodology: https://510kreport.com/methodology