B-One Ortho, Corp.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “B-One Ortho, Corp.” (first 2018, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. Since 2017 the median was 88 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 2 | 269 |
| 2019 | 2 | 114 |
| 2020 | 1 | 59 |
| 2021 | 3 | 61 |
| 2022 | 2 | 58 |
| 2023 | 0 | — |
| 2024 | 1 | 266 |
| 2025 | 0 | — |
| 2026 | 2 | 128 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name B-One Ortho, Corp. took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 7 | 7 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 4 | 4 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 1 | 1 |
Review panels
- Orthopedic (13)
Most recent B-One Ortho, Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions | JWH | 2026-09-08 | 60 |
| K253357 | b-ONE® Bipolar Head | KWY | 2026-04-13 | 195 |
| K240528 | b-ONE® Total Hip System | LZO | 2024-11-15 | 266 |
| K222431 | b-ONER MOBIO Total Knee System | JWH | 2022-10-06 | 56 |
| K213673 | b-ONE MOBIO Total Knee System | JWH | 2022-01-21 | 60 |
| K212912 | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System | MAI | 2021-11-04 | 52 |
| K210483 | MOBIO Total Knee System | JWH | 2021-04-21 | 61 |
| K202768 | KOSMO Femoral Stem | LZO | 2021-04-01 | 192 |
| K202429 | Mobio Total Knee System | JWH | 2020-10-23 | 59 |
| K182705 | Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups | LZO | 2019-02-14 | 140 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named B-One Ortho, Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under B-One Ortho, Corp.?
FDA lists 13 510(k) clearances under the applicant name “B-One Ortho, Corp.” (first 2018, latest 2026), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by B-One Ortho, Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name B-One Ortho, Corp. is 88 days. Since 2017: 88 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under B-One Ortho, Corp.?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 7); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 4); KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, 1).
Next steps
- See all 13 B-One Ortho, Corp. clearances with predicates and recalls
- Run predicate analysis for product code JWH, B-One Ortho, Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.