K241148 is an FDA 510(k) clearance for the Salto Talaris Ankle PSI System. This device is classified as a Ankle Arthroplasty Implantation System (Class II - Special Controls, product code OYK).
Submitted by 3D Systems, Inc. (Littleton, US). The FDA issued a Cleared decision on August 30, 2024, 127 days after receiving the submission on April 25, 2024.
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 | K241148 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2024 |
| Decision Date | August 30, 2024 |
| Days to Decision | 127 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. |