OWW · Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | OWW |
|---|---|
| Device Name | Mesh, Surgical, Absorbable, 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 (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) | Alafair Biosciences | Jul 18, 2025 | SESE |
| K250021 | Rotium | Nanofiber Solutions, LLC | Feb 27, 2025 | SESE |
| K242187 | BioBrace® | Conmed Corporation | Nov 27, 2024 | SESE |
| K241906 | BioBrace® Reinforced Implant | Conmed Corporation | Jul 29, 2024 | SESE |
| K240817 | VersaWrap | Alafair Biosciences, Inc. | Jun 14, 2024 | SESE |
| K222220 | SpinMedix Absorbable Fibrous Membrane | Celestray Biotech Company, LLC., | Jul 6, 2023 | SESE |
| K230316 | FlexBand; FlexPatch; FlexBand Plus | International Life Sciences | May 26, 2023 | SESE |
| K203267 | The BioBrace Implant | Biorez, Inc. | Apr 30, 2021 | SESE |
| K160364 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | Jun 10, 2016 | SESE |
| K121216 | STR GRAFT | Soft Tissue Regeneration, Inc. | Nov 21, 2012 | SESE |
Top Applicants
- Conmed Corporation — 2 clearances
- Alafair Biosciences, Inc. — 2 clearances
- Soft Tissue Regeneration, Inc. — 1 clearance
- Nanofiber Solutions, LLC — 1 clearance
- International Life Sciences — 1 clearance
