510(k) K254154 · PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
FX V135 EASYTECH® Shoulder System
| Applicant | FX Shoulder Solutions, Inc., Addison TX, US |
| Decision | Substantially Equivalent, May 1, 2026 |
| Received | Dec 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254154
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.