QAD · Class II · 21 CFR 888.3023

FDA Product Code QAD: Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activated

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.

Leading manufacturers include Illuminoss Medical, Inc..

7
Total
6
Cleared
114d
Avg days
2017
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activated Devices (Product Code QAD)

7 devices
1–7 of 7
Cleared Jan 19, 2024
IlluminOss Photodynamic Bone Stabilization System
K233436
Illuminoss Medical, Inc.
Orthopedic · 98d

About Product Code QAD - Regulatory Context

510(k) Submission Activity

7 total 510(k) submissions under product code QAD since 2017, with 6 receiving FDA clearance (average review time: 114 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QAD devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →