FDA product code OWX: Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
OWX is the FDA product code for mesh, surgical, non-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 5 510(k) submissions under OWX, 5 in the last five years, from 3 different applicants. The average 510(k) review took 160 days (median 202); 131 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, Non-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 OWX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 267 |
| 2024 | 1 | 224 |
| 2025 | 2 | 140 |
| 2026 | 1 | 30 |
Compare with all 510(k) review times · Search every OWX clearance
Top OWX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| ZuriMED Technologies AG | 2 | 2026-01-02 |
| Anika Therapeutics, Inc. | 2 | 2025-06-17 |
| Arthrex, Inc. | 1 | 2025-05-29 |
Most recent OWX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253867 | ZuriMED Technologies AG | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit | 2026-01-02 | 30 |
| K250997 | Anika Therapeutics, Inc. | Integrity Implant | 2025-06-17 | 77 |
| K243480 | Arthrex, Inc. | SuturePatch Tissue Reinforcement | 2025-05-29 | 202 |
| K241219 | ZuriMED Technologies AG | FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) | 2024-12-11 | 224 |
| K223538 | Anika Therapeutics, Inc. | Integrity Implant | 2023-08-17 | 267 |
Recalls for OWX devices
openFDA lists no recalls for product code OWX.
Frequently asked questions
What is FDA product code OWX?
OWX is the FDA product code for mesh, surgical, non-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 OWX?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OWX?
Across 5 cleared submissions the average was 160 days from receipt to decision (median 202).
Which companies have the most OWX clearances?
ZuriMED Technologies AG (2); Anika Therapeutics, Inc. (2); Arthrex, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OWX
- Run a recall and safety report across every OWX manufacturer
- Watch product code OWX 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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