510(k) K254128 ยท PHX Shoulder Prosthesis, Reverse Configuration
InSet Reverse Total Shoulder System
| Applicant | Shoulder Innovations, Inc., Grand Rapids MI, US |
| Decision | Substantially Equivalent, Apr 13, 2026 |
| Received | Dec 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254128
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.