510(k) K250644 ยท PHX Shoulder Prosthesis, Reverse Configuration
MSS - Monobloc stem
| Applicant | Medacta International S.A., Castel San Pietro, CH |
| Decision | Substantially Equivalent, Feb 3, 2026 |
| Received | Mar 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250644
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2026 | Medacta Usa Inc Short Monobloc Stem Broaches, Size/REF:
7/04.01.10.0970,
8/04.01.10.0971,
9/04.01.10.0972,
10/04.01.10.0973,
11/04.01.10.0974,
12/04.01.10.0975,
13/04.01.10.0976,
14/04.01.10.0977,
15/04.01.10.0978,
1 Open, Classified |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.