K210390 is an FDA 510(k) clearance for the Apex 3D Total Ankle Replacement System. This device is classified as a Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code HSN).
Submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on March 6, 2021, 25 days after receiving the submission on February 9, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3110.
| 510(k) Number | K210390 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2021 |
| Decision Date | March 06, 2021 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSN — Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3110 |