FDA product code QUW: Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
QUW is the FDA product code for mesh, surgical, non-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 5 510(k) submissions under QUW, 5 in the last five years, from 3 different applicants. The average 510(k) review took 108 days (median 56); 112 days on average over the last three years.
Definition
a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Non-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 QUW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 90 |
| 2025 | 2 | 203 |
| 2026 | 2 | 22 |
Compare with all 510(k) review times · Search every QUW clearance
Top QUW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Theramicro | 3 | 2026-08-18 |
| Xiros Limited | 1 | 2025-07-15 |
| Xiros, Ltd. | 1 | 2022-12-27 |
Most recent QUW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262729 | Theramicro | TeKBrace Solo Soft Tissue Reinforcement Device | 2026-08-18 | 18 |
| K261621 | Theramicro | TekBrace Solo Soft Tissue Reinforcement Device | 2026-06-09 | 25 |
| K242237 | Xiros Limited | Jewel Soft Tissue Reinforcement Device (102-6005) | 2025-07-15 | 350 |
| K251063 | Theramicro | TekBrace Solo Soft Tissue Reinforcement Device | 2025-05-30 | 56 |
| K222978 | Xiros, Ltd. | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | 2022-12-27 | 90 |
Recalls for QUW devices
openFDA lists no recalls for product code QUW.
Frequently asked questions
What is FDA product code QUW?
QUW is the FDA product code for mesh, surgical, non-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 QUW?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code QUW?
Across 5 cleared submissions the average was 108 days from receipt to decision (median 56).
Which companies have the most QUW clearances?
Theramicro (3); Xiros Limited (1); Xiros, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QUW
- Run a recall and safety report across every QUW manufacturer
- Watch product code QUW 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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