QAD — Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated Class II

FDA Device Classification

Classification Details

Product Code
QAD
Device Class
Class II
Regulation Number
888.3023
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Definition

Is a device intended to be implanted that consists of a polymeric balloon that is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. The balloon is infused with a liquid monomer that causes the balloon to fill the medullary canal of the fractured bone. The device is then exposed to a light source that polymerizes the light-activated monomer within the balloon creating a hardened rigid structure.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233436illuminoss medicalIlluminOss Photodynamic Bone Stabilization SystemJanuary 19, 2024
K202887illuminoss medicalIlluminOss Bone Stabilization SystemOctober 27, 2020
K201961illuminoss medicalIlluminOss Photodynamic Bone Stabilization SystemAugust 13, 2020
K200295illuminoss medicalIlluminOss Bone Stabilization SystemJune 25, 2020
K183145illuminoss medicalIlluminOss Photodynamic Bone Stabilization SystemDecember 13, 2018
K181228illuminoss medicalIlluminOss Bone Stabilization SystemAugust 31, 2018
DEN160062illminoss medicalIlluminOss Bone Stabilization SystemDecember 19, 2017