K243665 is an FDA 510(k) clearance for the Crius PEEK Suture Anchor System (Thread-Fix Anchor). This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).
Submitted by ZheJiang Decans Medical Devices Co., Ltd. (Jiaxing, CN). The FDA issued a Cleared decision on January 31, 2025, 65 days after receiving the submission on November 27, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K243665 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2024 |
| Decision Date | January 31, 2025 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBI - Fastener, Fixation, Nondegradable, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |