Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list B-One Ortho with 13 510(k) clearances. The most recent is a 510(k) clearance dated Sep 8, 2026: b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and P….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 8, 2026 | b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsK262341 · JWH | 510(k) clearances |
| Apr 13, 2026 | b-ONE® Bipolar HeadK253357 · KWY | 510(k) clearances |
| Nov 15, 2024 | b-ONE® Total Hip SystemK240528 · LZO | 510(k) clearances |
| Oct 6, 2022 | b-ONER MOBIO Total Knee SystemK222431 · JWH | 510(k) clearances |
| Jan 21, 2022 | b-ONE MOBIO Total Knee SystemK213673 · JWH | 510(k) clearances |
| Nov 4, 2021 | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula SystemK212912 · MAI | 510(k) clearances |
| Apr 21, 2021 | MOBIO Total Knee SystemK210483 · JWH | 510(k) clearances |
| Apr 1, 2021 | KOSMO Femoral StemK202768 · LZO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
