FDA product code QZZ: Limb And Joint Salvage Device With Coating For Bacteria Reduction
QZZ is the FDA product code for limb and joint salvage device with coating for bacteria reduction. It is a Class II device, regulated under 21 CFR 888.3900 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under QZZ, 2 in the last five years. The average 510(k) review took 146 days (median 146); 146 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Limb And Joint Salvage Device With Coating For Bacteria Reduction |
| Device class | Class II |
| Regulation | 21 CFR 888.3900 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for QZZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 33 |
| 2026 | 1 | 259 |
Compare with all 510(k) review times · Search every QZZ clearance
Top QZZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Onkos Surgical, Inc. | 2 | 2026-06-08 |
Most recent QZZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253066 | Onkos Surgical, Inc. | ELEOS with NanoCept® Technology Limb Salvage System | 2026-06-08 | 259 |
| K252920 | Onkos Surgical, Inc. | ELEOS Limb Salvage System with NanoCept® Technology | 2025-10-15 | 33 |
Recalls for QZZ devices
openFDA lists no recalls for product code QZZ.
Frequently asked questions
What is FDA product code QZZ?
QZZ is the FDA product code for limb and joint salvage device with coating for bacteria reduction. It is a Class II device, regulated under 21 CFR 888.3900 and reviewed by the Orthopedic panel.
What device class is QZZ?
Class II, regulation 21 CFR 888.3900. Typical premarket route: 510(k).
How long does a 510(k) take for product code QZZ?
Across 2 cleared submissions the average was 146 days from receipt to decision (median 146).
Which companies have the most QZZ clearances?
Onkos Surgical, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QZZ
- Run a recall and safety report across every QZZ manufacturer
- Watch product code QZZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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