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# Intramedullary Fixation Rod Placed Into Class 2
- URL: https://www.fdaweb.com/intramedullary-fixation-rod-placed-into-class-2/
- Published: 2018-06-08T12:00:00.000Z
- Updated: 2026-09-15T00:11:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141638

*Federal Register* notice: FDA has classified the *in vivo* cured intramedullary fixation rod into Class 2 (special controls). The action was in response to a 2016 request by IlluminOss Medical for a *De Novo* classification of the IlluminOss Photodynamic Bone Stabilization System. The agency has identified the rod as a prescription implanted device consisting of a balloon that is inserted into the medullary canal of long bones for the fixation of fractures. The balloon is infused with, and completely encapsulates, a liquid monomer that is exposed to a curing agent that polymerizes the monomer within the balloon creating a hardened rigid structure. To view the notice, click here.