K223326 is an FDA 510(k) clearance for the Axiom PSR System. This device is classified as a Ankle Arthroplasty Implantation System (Class II - Special Controls, product code OYK).
Submitted by Restor3d (Durham, US). The FDA issued a Cleared decision on March 30, 2023, 150 days after receiving the submission on October 31, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3110. Intended To Be Used To Assist In The Implantation Of A Specific Ankle Arthroplasty Device. Indicated To Include Guiding Alignment, Making Or Establishing Cuts, And Sizing..
| 510(k) Number | K223326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2022 |
| Decision Date | March 30, 2023 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OYK - Ankle Arthroplasty Implantation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3110 |
| Definition | Intended To Be Used To Assist In The Implantation Of A Specific Ankle Arthroplasty Device. Indicated To Include Guiding Alignment, Making Or Establishing Cuts, And Sizing. |