510(k) K220418 · PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Tornier Perform Humeral System Stemless
| Applicant | Tornier, Inc., Bloomington MN, US |
| Decision | Substantially Equivalent, Sep 14, 2022 |
| Received | Feb 14, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220418
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2024 | Tornier, Inc stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder Open, Classified |
PKC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.