K181228 is an FDA 510(k) clearance for the IlluminOss Bone Stabilization System. This device is classified as a Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activated (Class II - Special Controls, product code QAD).
Submitted by Illuminoss Medical, Inc. (East Providence, US). The FDA issued a Cleared decision on August 31, 2018, 115 days after receiving the submission on May 8, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3023. 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) Number | K181228 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2018 |
| Decision Date | August 31, 2018 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | QAD - Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3023 |
| 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. |