FDA product code OWW: Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
OWW is the FDA product code for mesh, surgical, absorbable, orthopaedics, reinforcement of tendon. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Orthopedic panel. FDA has cleared 10 510(k) submissions under OWW, 7 in the last five years, from 8 different applicants. The average 510(k) review took 130 days (median 116); 65 days on average over the last three years. FDA has posted 3 recalls for OWW devices, 3 initiated in the last five years.
Definition
For reinforcement of soft tissue where weakness exists during tendon repair procedures.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon |
| 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 OWW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 176 |
| 2023 | 2 | 228 |
| 2024 | 3 | 78 |
| 2025 | 2 | 52 |
Compare with all 510(k) review times · Search every OWW clearance
Top OWW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Conmed Corporation | 2 | 2024-11-27 |
| Alafair Biosciences, Inc. | 2 | 2024-06-14 |
| Alafair Biosciences | 1 | 2025-07-18 |
| Nanofiber Solutions, LLC | 1 | 2025-02-27 |
| Celestray Biotech Company, LLC., | 1 | 2023-07-06 |
3 more applicants have OWW clearances. See the full list in Caduvo.
Most recent OWW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251655 | Alafair Biosciences | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) | 2025-07-18 | 49 |
| K250021 | Nanofiber Solutions, LLC | Rotium | 2025-02-27 | 55 |
| K242187 | Conmed Corporation | BioBrace® | 2024-11-27 | 125 |
| K241906 | Conmed Corporation | BioBrace® Reinforced Implant | 2024-07-29 | 28 |
| K240817 | Alafair Biosciences, Inc. | VersaWrap | 2024-06-14 | 81 |
Recalls for OWW devices
3 product recalls in 1 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-02-06.
| Year | Recalls |
|---|---|
| 2026 | 3 |
Frequently asked questions
What is FDA product code OWW?
OWW is the FDA product code for mesh, surgical, absorbable, orthopaedics, reinforcement of tendon. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Orthopedic panel.
What device class is OWW?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OWW?
Across 10 cleared submissions the average was 130 days from receipt to decision (median 116).
Which companies have the most OWW clearances?
Conmed Corporation (2); Alafair Biosciences, Inc. (2); Alafair Biosciences (1); Nanofiber Solutions, LLC (1); Celestray Biotech Company, LLC., (1).
Have OWW devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2026-02-06.
Next steps
- Run an FDA pathway report with predicate devices for product code OWW
- Run a recall and safety report across every OWW manufacturer
- Watch product code OWW 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