K243480 is an FDA 510(k) clearance for the SuturePatch Tissue Reinforcement. This device is classified as a Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon (Class II - Special Controls, product code OWX).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on May 29, 2025, 202 days after receiving the submission on November 8, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300. For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair..
| 510(k) Number | K243480 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2024 |
| Decision Date | May 29, 2025 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OWX — Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |
| Definition | For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair. |