510(k) K251686 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Tornier Humeral Reconstruction System Max (Tornier HRS Max)
| Applicant | Tornier, Inc., Bloomington MN, US |
| Decision | Substantially Equivalent, Oct 30, 2025 |
| Received | Jun 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251686
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2026 | Tornier, Inc Tornier HRS Max parts:
1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101
2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102
3. TORNIER HRS Max Trial, Cat. Open, Classified |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.