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Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

FDA product code QAD · 6 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3023
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2018-08-31 – 2024-01-19

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.

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