OWX · Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
General, Plastic Surgery · 21 CFR 878.3300 · Class 2
Overview
| Product Code | OWX |
|---|---|
| Device Name | Mesh, Surgical, Non-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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253867 | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit | ZuriMED Technologies AG | Jan 2, 2026 | SESE |
| K250997 | Integrity Implant | Anika Therapeutics, Inc. | Jun 17, 2025 | SESE |
| K243480 | SuturePatch Tissue Reinforcement | Arthrex, Inc. | May 29, 2025 | SESE |
| K241219 | FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) | ZuriMED Technologies AG | Dec 11, 2024 | SESE |
| K223538 | Integrity Implant | Anika Therapeutics, Inc. | Aug 17, 2023 | SESE |
Top Applicants
- ZuriMED Technologies AG — 2 clearances
- Anika Therapeutics, Inc. — 2 clearances
- Arthrex, Inc. — 1 clearance
