OWY · Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | OWY |
|---|---|
| Device Name | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
Classification Rationale
Class II.
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251690 | Arthrex SpeedFLEX Implant | Arthrex, Inc. | Sep 30, 2025 | SESE |
| K252647 | Tapestry Biointegrative Implant | Embody, Inc. | Sep 19, 2025 | SESE |
| K250109 | TYBR Collagen Gel | Tybr Health | Jun 6, 2025 | SESE |
| K243843 | Tendon Protect (50242) | Kerecis Limited | Jun 4, 2025 | SESE |
| K242631 | REGENETEN Bioinductive Implant | Smith & Nephew Inc., Endoscopy Div. | Nov 26, 2024 | SESE |
| K222501 | Regeneten Bioinductive Implant | Smith and Nephew, Inc. | May 11, 2023 | SESE |
| K220867 | Tapestry Biointegrative Implant | Embody, Inc. | May 23, 2022 | SESE |
| K212306 | Tapestry Biointegrative Implant | Embody, Inc. | Nov 2, 2021 | SESE |
| K201572 | TAPESTRY Biointegrative Implant | Embody, Inc. | Oct 19, 2020 | SESE |
| K151083 | BioBridge Collagen Matrix | Fibralign Corporation | Jan 8, 2016 | SESE |
| K140300 | COLLAGEN TENDON SHEET-DDI (CTS-DDI) | Rotation Medical, Inc. | Mar 26, 2014 | SESE |
| K133169 | MESO TENDON MATRIX | Kensey Nash Corporation Dba Dsm Biomedical | Dec 20, 2013 | SESE |
| K131143 | TRELLIS COLLAGEN RIBBON | Wrightmedicaltechnologyinc | Oct 7, 2013 | SESE |
| K120479 | MTF FASCIA | Musculoskeletal Transplant Foundation | Nov 8, 2012 | SESE |
Top Applicants
- Embody, Inc. — 4 clearances
- Wrightmedicaltechnologyinc — 1 clearance
- Tybr Health — 1 clearance
- Smith and Nephew, Inc. — 1 clearance
- Smith & Nephew Inc., Endoscopy Div. — 1 clearance
