K250021 is an FDA 510(k) clearance for the Rotium. This device is classified as a Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (Class II - Special Controls, product code OWW).
Submitted by Nanofiber Solutions, LLC (Dublin, US). The FDA issued a Cleared decision on February 27, 2025, 55 days after receiving the submission on January 3, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300. For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures..
| 510(k) Number | K250021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2025 |
| Decision Date | February 27, 2025 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OWW - Mesh, Surgical, 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 During Tendon Repair Procedures. |