ELEOS Limb Salvage System with NanoCept® Technology
FDA 510(k) K252920 · Onkos Surgical, Inc.
Submission
- Device name
- ELEOS Limb Salvage System with NanoCept® Technology
- Applicant
- Onkos Surgical, Inc.
Parsippany, NJ, US - Received
- September 12, 2025
- Decision date
- October 15, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| K253066 | ELEOS with NanoCept® Technology Limb Salvage SystemQZZ · Traditional | Onkos Surgical, Inc. | 06/08/2026SE |
More from Onkos Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253066 | ELEOS with NanoCept® Technology Limb Salvage SystemQZZ · Traditional | 06/08/2026SE |
| 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 Limb Salvage System with NanoCept® Technology cleared by the FDA?
ELEOS Limb Salvage System with NanoCept® Technology (K252920) received a 510(k) decision of Substantially Equivalent on October 15, 2025, 33 days after the submission was received.
What is the product code of K252920?
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.