DEN210058 is an FDA 510(k) submission for the ELEOSx™ Limb Salvage System. This device is classified as a Limb And Joint Salvage Device With Coating For Bacteria Reduction (Class II - Special Controls, product code QZZ).
Submitted by Onkos Surgical (Parsippany, US). The FDA issued a Not Cleared (DENG) decision on April 5, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3900. A Limb And Joint Salvage Device With Quaternary Ammonium Compound Coating Is A Metallic Implant With Or Without Polymer Bearing For Bone And Joint Replacement. Implants Are For Resection And Replacement Of An Extremity Bone (including The Entire Bone, Epiphyseal Bone, Metaphyseal Bone, Or Diaphyseal Bone), Or An Extremity Bone And The Surrounding Joint(s) In A Skeletally Mature Patient. The Device Includes A Quaternary Ammonium Compound Coating That Is Covalently Bonded To The Device. Where Applied, The Coating Is Intended To Reduce Microbial Contamination On The Surface Of The Device Prior To Implantation. The Device Does Not Contain Antimicrobial Agents That Act Within Or On The Body And This Device Type Does Not Include Combination Products..
| 510(k) Number | DEN210058 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 30, 2021 |
| Decision Date | April 05, 2024 |
| Days to Decision | 827 days |
| Submission Type | Direct |
| Review Panel | Orthopedic (OR) |
| Summary | - |
| Product Code | QZZ - Limb And Joint Salvage Device With Coating For Bacteria Reduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3900 |
| Definition | A Limb And Joint Salvage Device With Quaternary Ammonium Compound Coating Is A Metallic Implant With Or Without Polymer Bearing For Bone And Joint Replacement. Implants Are For Resection And Replacement Of An Extremity Bone (including The Entire Bone, Epiphyseal Bone, Metaphyseal Bone, Or Diaphyseal Bone), Or An Extremity Bone And The Surrounding Joint(s) In A Skeletally Mature Patient. The Device Includes A Quaternary Ammonium Compound Coating That Is Covalently Bonded To The Device. Where Applied, The Coating Is Intended To Reduce Microbial Contamination On The Surface Of The Device Prior To Implantation. The Device Does Not Contain Antimicrobial Agents That Act Within Or On The Body And This Device Type Does Not Include Combination Products. |