Onkos Surgical, Inc. · Class II · Cleared Oct 15, 2025
| K-number | K252920 |
| Device name | ELEOS Limb Salvage System with NanoCept® Technology |
| Applicant | Onkos Surgical, Inc. |
| Product code | QZZ |
| Device class | Class II |
| Decision date | Oct 15, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3900 |
The ELEOS™ Limb Salvage System with NanoCept® Technology is a reconstruction implant system for resection and replacement of proximal femur, femoral shaft, total femur, distal femur, and proximal tibia in skeletally mature patients with degenerative joint disease, trauma, or oncologic conditions. The device includes an antibacterial coating to reduce bacterial contamination on the device surface prior to implantation from the operating room environment.
The subject device applies a covalently bound quaternary ammonium compound (MDPB) antibacterial coating to cobalt-chromium proximal tibia components that were previously cleared without coating. The coating reduces contamination on the device surface prior to implantation by killing bacteria external to the patient and does not act within or on the patient's body.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov