K231657 is an FDA 510(k) clearance for the AGILON® XO Shoulder Replacement System. This device is classified as a Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (Class II - Special Controls, product code KWT).
Submitted by Implantcast GmbH (Buxtehude, DE). The FDA issued a Cleared decision on February 16, 2024, 254 days after receiving the submission on June 7, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3650.
| 510(k) Number | K231657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2023 |
| Decision Date | February 16, 2024 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWT — Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3650 |