FDA product code OWY: Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
OWY is the FDA product code for mesh, surgical, collagen, 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 14 510(k) submissions under OWY, 7 in the last five years, from 11 different applicants. The average 510(k) review took 136 days (median 125); 100 days on average over the last three years.
Definition
For reinforcement of soft tissue where weakness exists in tendon repair.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Collagen, 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 OWY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 130 |
| 2021 | 1 | 102 |
| 2022 | 1 | 59 |
| 2023 | 1 | 266 |
| 2024 | 1 | 84 |
| 2025 | 4 | 116 |
Compare with all 510(k) review times · Search every OWY clearance
Top OWY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Embody, Inc. | 4 | 2025-09-19 |
| Arthrex, Inc. | 1 | 2025-09-30 |
| Tybr Health | 1 | 2025-06-06 |
| Kerecis Limited | 1 | 2025-06-04 |
| Smith & Nephew Inc., Endoscopy Div. | 1 | 2024-11-26 |
6 more applicants have OWY clearances. See the full list in Caduvo.
Most recent OWY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251690 | Arthrex, Inc. | Arthrex SpeedFLEX Implant | 2025-09-30 | 120 |
| K252647 | Embody, Inc. | Tapestry Biointegrative Implant | 2025-09-19 | 29 |
| K250109 | Tybr Health | TYBR Collagen Gel | 2025-06-06 | 141 |
| K243843 | Kerecis Limited | Tendon Protect (50242) | 2025-06-04 | 173 |
| K242631 | Smith & Nephew Inc., Endoscopy Div. | REGENETEN Bioinductive Implant | 2024-11-26 | 84 |
Recalls for OWY devices
openFDA lists no recalls for product code OWY.
Frequently asked questions
What is FDA product code OWY?
OWY is the FDA product code for mesh, surgical, collagen, 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 OWY?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OWY?
Across 14 cleared submissions the average was 136 days from receipt to decision (median 125).
Which companies have the most OWY clearances?
Embody, Inc. (4); Arthrex, Inc. (1); Tybr Health (1); Kerecis Limited (1); Smith & Nephew Inc., Endoscopy Div. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OWY
- Run a recall and safety report across every OWY manufacturer
- Watch product code OWY 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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