510(k) K262341 · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions
| Applicant | B-One Ortho, Corp., Cedar Knolls NJ, US |
| Decision | Substantially Equivalent, Sep 8, 2026 |
| Received | Jul 10, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262341
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.