Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
B-One Ortho, Corp. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
266 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253357 | b-ONE® Bipolar Head | B-One Ortho, Corp. | 2026-04-13 | 195 | 0 |
| K240528 | b-ONE® Total Hip System | B-One Ortho, Corp. | 2024-11-15 | 266 | 0 |
| K222431 | b-ONER MOBIO Total Knee System | B-One Ortho, Corp. | 2022-10-06 | 56 | 0 |
| K213673 | b-ONE MOBIO Total Knee System | B-One Ortho, Corp. | 2022-01-21 | 60 | 0 |
| K212912 | OneFix Biocomposite Anchors, OneFix Biocomposite Small Ancho | B-One Ortho, Corp. | 2021-11-04 | 52 | 0 |
| K210483 | MOBIO Total Knee System | B-One Ortho, Corp. | 2021-04-21 | 61 | 0 |
| K202768 | KOSMO Femoral Stem | B-One Ortho, Corp. | 2021-04-01 | 192 | 0 |
| K202429 | Mobio Total Knee System | B-One Ortho, Corp. | 2020-10-23 | 59 | 0 |
| K182705 | Juveno Hip System Femoral Stem, b-ONE Primary Acetabular Sys | B-One Ortho, Corp. | 2019-02-14 | 140 | 0 |
| K183025 | MOBIO Total Knee System Posterior Stabilized (PS and PS+) Ti | B-One Ortho, Corp. | 2019-01-28 | 88 | 0 |
| K180446 | b-ONE Total Knee System | B-One Ortho, Corp. | 2018-10-12 | 234 | 0 |
| K173380 | b-ONE® Total Hip System | B-One Ortho, Corp. | 2018-08-30 | 304 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda