K253867 is an FDA 510(k) clearance for the FiberLocker Implant. This device is classified as a Mesh, Surgical, Non-absorbable, Orthopaedics, Reinforcement Of Tendon (Class II - Special Controls, product code OWX).
Submitted by ZuriMED Technologies AG (Zurich, CH). The FDA issued a Cleared decision on January 2, 2026, 30 days after receiving the submission on December 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 In Tendon Repair..
| 510(k) Number | K253867 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2025 |
| Decision Date | January 02, 2026 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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. |