K221128 is an FDA 510(k) clearance for the Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II. This device is classified as a Fastener, Fixation, Biodegradable, Soft Tissue (Class II - Special Controls, product code MAI).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on October 5, 2022, 170 days after receiving the submission on April 18, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K221128 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2022 |
| Decision Date | October 05, 2022 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MAI — Fastener, Fixation, Biodegradable, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |