FDA product code QBO: Instruments Designed For Press-Fit Osteochondral Implants
QBO is the FDA product code for instruments designed for press-fit osteochondral implants. It is a Class II device, regulated under 21 CFR 888.4505 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under QBO. The average 510(k) review took 28 days (median 28).
Definition
The device is intended to manipulate bone and cartilage tissue or implant materials for the positioning, alignment, defect creation, or placement of press-fit osteochondral implants.
Classification
| Field | Value |
|---|---|
| Device name | Instruments Designed For Press-Fit Osteochondral Implants |
| Device class | Class II |
| Regulation | 21 CFR 888.4505 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
510(k) clearances per year for QBO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 30 |
| 2019 | 1 | 26 |
Top QBO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cartiva, Inc. | 2 | 2019-09-04 |
Most recent QBO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192156 | Cartiva, Inc. | Cartiva SCI instrumentation set | 2019-09-04 | 26 |
| K181348 | Cartiva, Inc. | Cartiva SCI Disposable Instrumentation Set | 2018-06-20 | 30 |
Recalls for QBO devices
openFDA lists no recalls for product code QBO.
Frequently asked questions
What is FDA product code QBO?
QBO is the FDA product code for instruments designed for press-fit osteochondral implants. It is a Class II device, regulated under 21 CFR 888.4505 and reviewed by the Orthopedic panel.
What device class is QBO?
Class II, regulation 21 CFR 888.4505. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code QBO?
Across 2 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most QBO clearances?
Cartiva, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QBO
- Run a recall and safety report across every QBO manufacturer
- Watch product code QBO 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.