K203421 is an FDA 510(k) clearance for the Triathlon AS-1. This device is classified as a Knee Arthroplasty Implantation System (Class II - Special Controls, product code OOG).
Submitted by Conformis, Inc. (Billerica, US). The FDA issued a Cleared decision on April 19, 2021, 150 days after receiving the submission on November 20, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560. Intended To Be Used To Assist In The Implantation Of A Specific Knee Arthroplasty Device Or A Set Of Specific Knee Arthroplasty Devices. Indicated To Include Guiding Alignment, Making Or Establishing Cuts, Selecting, Sizing, Attaching, Positioning Or Orienting Implant Components..
| 510(k) Number | K203421 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2020 |
| Decision Date | April 19, 2021 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OOG — Knee Arthroplasty Implantation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3560 |
| Definition | Intended To Be Used To Assist In The Implantation Of A Specific Knee Arthroplasty Device Or A Set Of Specific Knee Arthroplasty Devices. Indicated To Include Guiding Alignment, Making Or Establishing Cuts, Selecting, Sizing, Attaching, Positioning Or Orienting Implant Components. |