DeviceClearance

Product code QAD— Orthopedic

IlluminOss Bone Stabilization System

Classification name
Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
Device class
Class 2
Regulation
21 CFR 888.3023
Advisory panel
Orthopedic
Total cleared
7
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QAD under 21 CFR 888.3023, via openFDA

Market context for product code QAD

FDA has cleared 7 devices under product code QAD between 2017 and 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QAD

Adverse events under product code QAD

product code QAD
Death
13
Total
13

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code QAD

Data sourced from openFDA. This site is unofficial and independent of the FDA.