ELEOS with NanoCept® Technology Limb Salvage System
FDA 510(k) K253066 · Onkos Surgical, Inc.
Submission
- Device name
- ELEOS with NanoCept® Technology Limb Salvage System
- Applicant
- Onkos Surgical, Inc.
Parsippany, NJ, US - Received
- September 22, 2025
- Decision date
- June 8, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QZZ – Limb And Joint Salvage Device With Coating For Bacteria Reduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3900
- Specialty
- Orthopedic
- Implant
- Yes
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…
Other 510(k)s with product code QZZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252920 | ELEOS Limb Salvage System with NanoCept® TechnologyQZZ · Special | Onkos Surgical, Inc. | 10/15/2025SE |
More from Onkos Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252920 | ELEOS Limb Salvage System with NanoCept® TechnologyQZZ · Special | 10/15/2025SE |
| K223348 | My3D® Personalized Pelvic ReconstructionLPH · Traditional | 01/30/2023SE |
| K212815 | My3D® Personalized Pelvic ReconstructionLPH · Traditional | 07/06/2022SE |
| K211677 | ELEOS Limb Salvage SystemKRO · Traditional | 07/28/2021SE |
| K203815 | ELEOS Limb Salvage System with BioGripJDI · Traditional | 06/09/2021SE |
| K203588 | ELEOS Limb Salvage SystemJDI · Traditional | 02/05/2021SE |
| K203090 | ELEOS Limb Salvage System featuring BIOGRIPJDI · Traditional | 12/11/2020SE |
| K180130 | ELEOS Bipolar Acetabular SystemKWY · Traditional | 02/23/2018SE |
| K161520 | ELEOS Limb Salvage SystemKRO · Traditional | 10/28/2016SE |
Questions and answers
When was ELEOS with NanoCept® Technology Limb Salvage System cleared by the FDA?
ELEOS with NanoCept® Technology Limb Salvage System (K253066) received a 510(k) decision of Substantially Equivalent on June 8, 2026, 259 days after the submission was received.
What is the product code of K253066?
The FDA product code is QZZ – Limb And Joint Salvage Device With Coating For Bacteria Reduction, a Class II (moderate risk) device regulated under 21 CFR 888.3900.