FDA product code QHQ: Total Shoulder Arthroplasty System
QHQ is the FDA product code for total shoulder arthroplasty system. It is a Class II device, regulated under 21 CFR 888.3660 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under QHQ. The average 510(k) review took 249 days (median 249). FDA has posted 1 recall for QHQ devices, 1 initiated in the last five years.
Definition
To treat pain and lack of function in the shoulder.
Classification
| Field | Value |
|---|---|
| Device name | Total Shoulder Arthroplasty System |
| Device class | Class II |
| Regulation | 21 CFR 888.3660 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for QHQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 249 |
Compare with all 510(k) review times · Search every QHQ clearance
Top QHQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arthrex, Inc. | 1 | 2019-07-26 |
Most recent QHQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K183194 | Arthrex, Inc. | Arthrex Eclipse Shoulder Prosthesis System | 2019-07-26 | 249 |
Recalls for QHQ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-05-20.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code QHQ?
QHQ is the FDA product code for total shoulder arthroplasty system. It is a Class II device, regulated under 21 CFR 888.3660 and reviewed by the Orthopedic panel.
What device class is QHQ?
Class II, regulation 21 CFR 888.3660. Typical premarket route: 510(k).
How long does a 510(k) take for product code QHQ?
Across 1 cleared submissions the average was 249 days from receipt to decision (median 249).
Which companies have the most QHQ clearances?
Arthrex, Inc. (1).
Have QHQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-05-20.
Next steps
- Run an FDA pathway report with predicate devices for product code QHQ
- Run a recall and safety report across every QHQ manufacturer
- Watch product code QHQ 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times