K222161 is an FDA 510(k) clearance for the Arthrex Knotless FiberTak Biceps Suture Anchor. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on August 11, 2022, 22 days after receiving the submission on July 20, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K222161 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 2022 |
| Decision Date | August 11, 2022 |
| Days to Decision | 22 days |
| Submission Type | Special |
| 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 |