Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
The Rod, Fixation, Intramedullary and Accessories, In-Vivo Cured, Light-Activated is an implantable orthopedic device consisting of a polymeric balloon inserted into the medullary canal of long bones for fracture fixation; after insertion, the balloon is infused with a liquid monomer and exposed to light, which polymerizes the monomer to create a hardened, rigid intramedullary fixation structure. It is classified as a Class 2 device under regulation 888.3023, requiring 510(k) premarket notification, and falls within the Orthopedic (OR) medical specialty. The product code is QAD. It is flagged as an implant.
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Basic Information
- Product Code
- QAD
- Device Class
- FDA class 2
- Regulation Number
- 888.3023
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233436 | IlluminOss Photodynamic Bone Stabilization System | Jan 19, 2024 | Substantially Equivalent | Illuminoss Medical, Inc. |
| K202887 | IlluminOss Bone Stabilization System | Oct 27, 2020 | Substantially Equivalent | Illuminoss Medical, Inc. |
| K201961 | IlluminOss Photodynamic Bone Stabilization System | Aug 13, 2020 | Substantially Equivalent | Illuminoss Medical, Inc. |
| K200295 | IlluminOss Bone Stabilization System | Jun 25, 2020 | Substantially Equivalent | Illuminoss Medical, Inc. |
| K183145 | IlluminOss Photodynamic Bone Stabilization System | Dec 13, 2018 | Substantially Equivalent | Illuminoss Medical, Inc. |
| K181228 | IlluminOss Bone Stabilization System | Aug 31, 2018 | Substantially Equivalent | Illuminoss Medical, Inc. |
| DEN160062 | IlluminOss Bone Stabilization System | Dec 19, 2017 | Unknown | Illminoss Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.