510(k) K190085 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Journey II Unicompartmental Knee System
| Applicant | Smith & Nephew, Inc., Cordova TN, US |
| Decision | Substantially Equivalent, Feb 11, 2019 |
| Received | Jan 17, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190085
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 14, 2023 | Smith & Nephew, Inc. JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM Open, Classified |
HSX | None listed |
| Jan 28, 2020 | Smith & Nephew, Inc. JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to asses Terminated |
HSX | None listed |
| Jan 28, 2020 | Smith & Nephew, Inc. JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to asses Terminated |
HSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.