Limb And Joint Salvage Device With Coating For Bacteria Reduction
The limb and joint salvage device with coating for bacteria reduction (product code QZZ) is a Class 2 Orthopedic implantable device (regulation 888.3900) consisting of a metallic implant with or without a polymer bearing intended for resection and replacement of an extremity bone or an extremity bone and surrounding joint(s) in skeletally mature patients, with a quaternary ammonium compound coating covalently bonded to the device to reduce microbial contamination on its surface prior to implantation. Requiring 510(k) clearance, the device does not contain antimicrobial agents that act within or on the body, and does not include combination products. It is classified as an implant but is not life-sustaining.
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Basic Information
- Product Code
- QZZ
- Device Class
- FDA class 2
- Regulation Number
- 888.3900
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253066 | ELEOS with NanoCept® Technology Limb Salvage System | Jun 08, 2026 | Substantially Equivalent | Onkos Surgical, Inc. |
| K252920 | ELEOS Limb Salvage System with NanoCept® Technology | Oct 15, 2025 | Substantially Equivalent | Onkos Surgical, Inc. |
| DEN210058 | ELEOSx Limb Salvage System | Apr 05, 2024 | Unknown | Onkos Surgical |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.