OWY
14 FDA 510(k) clearances · Product code
130 daysmedian time to decision
266 days90th percentile
14clearances measured
FDA profile
- Official device name
- Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- FDA definition
- For reinforcement of soft tissue where weakness exists in tendon repair.
- Adverse events (MAUDE)
- 2020: 14 · 2021: 25 · 2022: 15 · 2023: 35 · 2024: 24 · 2025: 28
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Arthrex SpeedFLEX™ Implant (K251690) | Arthrex, Inc. | 2025-09-30 |
| Tapestry Biointegrative Implant (K252647) | Embody, Inc. | 2025-09-19 |
| TYBR Collagen Gel (K250109) | Tybr Health | 2025-06-06 |
| Tendon Protect (50242) (K243843) | Kerecis Limited | 2025-06-04 |
| REGENETEN™ Bioinductive Implant (K242631) | Smith & Nephew Inc., Endoscopy Div. | 2024-11-26 |
| Regeneten Bioinductive Implant (K222501) | Smith and Nephew, Inc. | 2023-05-11 |
| Tapestry Biointegrative Implant (K220867) | Embody, Inc. | 2022-05-23 |
| Tapestry Biointegrative Implant (K212306) | Embody, Inc. | 2021-11-02 |
| TAPESTRY Biointegrative Implant (K201572) | Embody, Inc. | 2020-10-19 |
| BioBridge Collagen Matrix (K151083) | Fibralign Corporation | 2016-01-08 |
| COLLAGEN TENDON SHEET-DDI (CTS-DDI) (K140300) | Rotation Medical, Inc. | 2014-03-26 |
| MESO TENDON MATRIX (K133169) | Kensey Nash Corporation Dba Dsm Biomedical | 2013-12-20 |
| TRELLIS COLLAGEN RIBBON (K131143) | Wrightmedicaltechnologyinc | 2013-10-07 |
| MTF FASCIA (K120479) | Musculoskeletal Transplant Foundation | 2012-11-08 |
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Every clearance here is in the API, with alerts when new ones post.