FDA product code QWJ: Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament
QWJ is the FDA product code for mesh, surgical, polymeric, resorbable, orthopedics, reinforcement of ligament. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under QWJ, 1 in the last five years. The average 510(k) review took 69 days (median 69); 69 days on average over the last three years.
Definition
For reinforcement of soft tissue where weakness exists in ligament repair
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | OR — Orthopedic |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for QWJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 69 |
Compare with all 510(k) review times · Search every QWJ clearance
Top QWJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| International Life Sciences | 1 | 2026-04-09 |
Most recent QWJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260317 | International Life Sciences | Artelon Convenience Kits | 2026-04-09 | 69 |
Recalls for QWJ devices
openFDA lists no recalls for product code QWJ.
Frequently asked questions
What is FDA product code QWJ?
QWJ is the FDA product code for mesh, surgical, polymeric, resorbable, orthopedics, reinforcement of ligament. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Orthopedic panel.
What device class is QWJ?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code QWJ?
Across 1 cleared submissions the average was 69 days from receipt to decision (median 69).
Which companies have the most QWJ clearances?
International Life Sciences (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QWJ
- Run a recall and safety report across every QWJ manufacturer
- Watch product code QWJ 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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