510(k) K211359 · PHX Shoulder Prosthesis, Reverse Configuration
Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation
| Applicant | Tornier, Inc., Bloomington MN, US |
| Decision | Substantially Equivalent, Nov 12, 2021 |
| Received | May 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211359
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2025 | Tornier S.A.S. Blueprint Software, BPUE001.
Intended for use by surgeons as a pre surgical planner for shoulder replacement. Open, Classified |
PHX | None listed |
| May 22, 2024 | Tornier S.A.S. Stryker Blueprint Software, Catalog #BPUE001. Open, Classified |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.